[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelofibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelofibrosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,58,0,25,[9,42,74,107,133,160,181,202,235,262,287,312,334,357,377,425,465,487,508,535,558,594,624,645,674],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100542640","phase-2-high-dose-ruxolitinib-and-allogeneic-stem-cell-transplantation-in-myelofibrosis-patients-with-splenomegaly-100542640",false,"NCT06345495","High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly","Inclusion Criteria:\n\n1. Participants 18 years to less than or equal to 75 years.\n2. Able to provide written consent.\n3. Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)\n4. Enlarged spleen by palpation or imaging. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging.\n5. Has a fully matched (8\u002F8:HLA A, B, C, DRB1) related or matched unrelated donor.\n6. Adequate renal function, including:\n\n   a. Serum creatinine \\\u003C\u002F= 1.5 mg\u002FdL or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) \\>\u002F= 40 ml\u002Fmin\u002F1.73 m2.\n7. Adequate liver function, including:\n\n   1. ALT\u002FAST \\\u003C\u002F= 3 x ULN\n   2. Direct bilirubin \\\u003C\u002F= 1mg\u002FdL\n   3. No history of liver cirrhosis. No ascites.\n8. Female participants of childbearing potential must have negative results for a serum pregnancy test. Female participants must agree to not breastfeed during the study and for 3 months post-completion of the study therapy.\n9. Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. Highly effective methods of contraception include the following:\n\n   1. Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n   2. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n\nExclusion Criteria:\n\n1. Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Ejection fraction \\\u003C40%\n3. Corrected DLCO \\\u003C 50%\n4. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   2. Active hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same.\n   3. Thrombosis including MI, Stroke, PE, DVT in the past 6 months\n\nNote: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.",[27,28],"Splenomegaly","Myelofibrosis","RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":33},"2024-10-01",{"date":37,"type":21},"2029-01-01",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":20},"100463861","phase-1-study-of-disc-0974-rally-mf-in-participants-with-myelofibrosis-or-myelodysplastic-syndrome-and-anemia-100463861","NCT05320198","Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","RALLY-MF: A Phase 1b\u002F2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","Inclusion Criteria for Participants with MF and Anemia:\n\nParticipants are eligible for the study if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the informed consent form (ICF).\n2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and\u002For post ET MF, as confirmed in the most recent local bone marrow biopsy report, according to World Health Organization (WHO) 2016 criteria.\n\n   For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included.\n3. Washout of at least 28 days prior to Screening of the following treatments:\n\n   1. Androgens\n   2. EPO\n   3. Cladribine\n   4. Immunomodulators (lenalidomide, thalidomide)\n   5. Luspatercept\u002Fsotatercept\n   6. Systemic corticosteroids are permitted for non-hematological conditions if stable or decreasing dose for ≥28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening.\n\n   Screening can begin before the 28 day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   For Phase 1b: Hgb \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD cohort. The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of ≥6 units PRBC over the 84 days immediately prior to Screening. There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening.\n\n   For Phase 2:\n\n   TD high transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 3 to 12 PRBC units over the 84 days immediately prior to Screening TD low transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 1 to 2 PRBC units over the 84 days immediately prior to Screening nTD Cohort: Non-transfusion dependence, baseline Hgb \\\u003C10 g\u002FdL as defined on ≥3 assessments over 84 days prior to Screening, without RBC transfusion\n5. Stable dosing of MF-directed therapy:\n\n   1. Hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening.\n   2. Interferon alpha stable dosing for at least 12 weeks prior to Screening.\n   3. JAK inhibitors require 12 weeks of stable dosing prior to Screening. For the TD high, TD low, and nTD cohorts, JAK inhibitors allowed include momelotinib, pacritinib, fedratinib, and ruxolitinib.\n   4. If the participant discontinues JAK inhibitor (including momelotinib\u002Fpacritinib\u002Fruxolitinib\u002Ffedratinib) and\u002For hydroxyurea prior to Screening, a 60-day washout period is required.\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2.\n7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.\n8. TSAT \\\u003C75% (local lab acceptable) at or within 2 weeks of Screening.\n9. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review. Required for TD high participants only.\n10. Serum ferritin ≥50 µg\u002FL at Screening.\n11. Platelet count ≥25,000\u002FµL and \\\u003C1,000,000\u002FµL; neutrophils ≥1,000\u002FµL; and total white blood cell (WBC) count \\\u003C50,000\u002FµL at Screening.\n12. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.\n13. Aspartate aminotransferase (AST) and ALT \\\u003C3.0x upper limit of normal (ULN) at Screening.\n14. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.\n15. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n16. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n17. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n18. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n19. Able to comply with all study procedures.\n\nInclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:\n\nParticipants are eligible for the MDS exploratory cohort if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the ICF.\n2. Molecular International Prognostic Scoring System (IPSS-M) classification of very low, low, or intermediate (ie, lower risk) MDS-ringed sideroblasts (RS) negative, MDS\u002FMPN with ringed sideroblasts and thrombocytosis (RS-T), Chronic Myelomonocytic Leukemia (CMML), Atypical Chronic Myeloid Leukemia (aCML), or Myelodysplastic\u002FMyeloproliferative Neoplasms, Unclassifiable (MDS\u002FMPN-U) as confirmed in the most recent local bone marrow biopsy report according to WHO criteria.\n3. Washout of at least 28 days is required for prior anemia\u002Fneutropenia-directed therapies, including:\n\n   1. Androgens\n   2. EPO-stimulating agents\n   3. Luspatercept\n   4. Sotatercept (ACE-011)\n   5. Imetelstat\n   6. Granulocyte colony-stimulating factor (G CSF) OR granulocyte-macrophage CSF (GM CSF).\n   7. Systemic corticosteroids (except for participants on a stable or decreasing dose for ≥28 days prior to randomization for non-hematological conditions and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening) Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   1. Baseline Hgb of \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically during the 84 days prior to Screening\n   2. Medical history of ≤24 units of PRBC for MDS and anemia\n5. ECOG performance score ≤2\n6. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening\n7. TSAT \\\u003C75% (local lab acceptable) at or within 2 weeks of Screening\n8. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review\n9. Serum ferritin ≥50 μg\u002FL at Screening\n10. Platelet count ≥25,000\u002FμL and \\\u003C1,000,000\u002FμL, and total WBC count \\\u003C50,000\u002FμL at Screening or otherwise approved by Sponsor.\n11. eGFR ≥30 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI formula\n12. AST and ALT \\\u003C3x ULN at Screening\n13. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.\n14. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n15. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum FSH levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n16. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n17. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n18. Able to comply with all study procedures.\n\nExclusion Criteria for Participants with MF and Anemia:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical History, Participants with MF and Anemia\n\n1. Hereditary hemochromatosis\n2. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n3. Total splenectomy\n4. Hematopoietic cell transplant within the past 2 years, or graft vs host disease requiring immunosuppression\n5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n6. Active immune-mediated hemolytic anemia\n7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n9. Malignancy within the past 3 years, other than primary MF, post ET, or post PV MF. The following history or concurrent conditions are allowed:\n\n   1. basal or squamous cell carcinoma of the skin\n   2. carcinoma in situ of the cervix or the breast\n   3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 3 months prior to Screening\n11. Known allergic reaction to any study drug excipient\n12. A history of anti-drug antibody formation\n13. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n14. Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral load\n15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Participants with MF and Anemia\n16. Iron chelation therapy in the 28 days prior to Screening\n17. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Participants with MF and Anemia\n18. Peripheral blood myeloblasts ≥10% of WBC differential at most recent evaluation prior to Screening\n19. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Participants with MF and Anemia\n20. Pregnant or lactating\n21. Condition or concomitant medication that would confound the ability to interpret study data\n22. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening\n\nExclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:\n\nParticipants are excluded from the MDS exploratory cohort if any of the following criteria apply:\n\nMedical History, Participants with MDS and Anemia\n\n1. Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation from other diseases\n2. Peripheral blasts ≥5%\n3. Current treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy or planned use within 6 months after Screening\n4. Prior treatment with \\>3 anemia-directed therapies (unless otherwise approved by Sponsor) including:\n\n   1. Luspatercept\n   2. Sotatercept (ACE-011)\n   3. EPO-stimulating agent\n   4. Imetelstat\n5. Hereditary hemochromatosis\n6. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n7. Total splenectomy\n8. Hematopoietic cell transplant within the past 10 years\n9. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n10. Active immune-mediated hemolytic anemia\n11. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n12. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n13. Malignancy within the past 3 years, other than MDS or MDS\u002FMPN without excess blasts. The following history or concurrent conditions are allowed:\n\n    1. Basal or squamous cell carcinoma of the skin\n    2. Carcinoma in situ of the cervix or the breast\n    3. Histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n14. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening\n15. Known allergic reaction to any study drug excipient\n16. A history of antidrug antibody formation\n17. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n18. Active hepatitis B or C, or HIV with detectable viral load\n19. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Participants with MDS and Anemia\n20. Iron chelation therapy in the 28 days prior to Screening\n21. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Participants with MDS and Anemia\n22. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Participants with MDS and Anemia\n23. Pregnant or lactating\n24. Condition or concomitant medication that would confound the ability to interpret study data\n25. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n26. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening",{"count":50,"type":21},150,[52,24],"PHASE1","This phase 1b\u002F2a open-label study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DISC-0974 as well as categorize the effects on hematologic response in participants with myelofibrosis or myelodysplastic syndrome and anemia.",[55,56,28,57,58,59,60],"Myelofibrosis; Anemia","Anemia","Myelofibrosis Due to and Following Polycythemia Vera","Primary Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Myelodysplastic Syndromes",[62,63],"Myeloproliferative Neoplasm","Myeloproliferative Disorders","2026-08-10",{"date":66,"type":33},"2026-08-12",{"date":68,"type":33},"2022-06-06",{"date":70,"type":21},"2027-06",{"name":72,"class":73},"Disc Medicine, Inc","INDUSTRY",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":96,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100650604","flonoltinib-maleate-oral-regimens-in-patients-with-myelofibrosis-100650604","NCT07750574","Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis","A Randomized, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Oral Flonoltinib Maleate in Patients With JAK Inhibitor Treatment-Naïve or Resistant Myelofibrosis","FM-MF-02","Inclusion Criteria:\n\nAll participants must:\n\n1. Have signed the current relevant ICF prior to any study related procedures;\n2. Understand and commit to comply with study requirements;\n3. Be ≥18 years of age;\n4. Be able to swallow and retain oral medications;\n5. Be diagnosed with PMF according to the 2016 WHO criteria, or PPV-MF or PET-MF according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria;\n6. Have Intermediate-1 to high-risk myelofibrosis (as per Dynamic International Prognostic Scoring System \\[DIPSS\\] risk categories) and be either JAKi-naïve or JAKi-resistant. JAKi-naïve patients include those with JAKi exposure of no more than 14 days. The JAKi-resistant patients need to meet 1 of the following criteria: a) Treatment with JAKi for 3 months with inadequate efficacy response defined as \\\u003C 10% spleen volume reduction (SVR) by Magnetic Resonance Imaging (MRI) or \\\u003C30% decrease from baseline in spleen size by palpation or regrowth to these parameters following an initial response; b) Treatment with JAKi for ≥28 days complicated by any of the following: development of a red blood cell transfusion requirement (at least 2 units\u002Fmonth for 2 months) or cytopenia-related intolerance requiring ≥2 dose reductions or discontinuation of a JAKi; c) Persistent MF-related symptoms defined as less than 50% reduction in TSS (MFSAF V 4.0) after 3 months of JAKi therapy;\n7. Not be intended to undergo stem cell transplantation for at least 6 months;\n8. Have life expectancy per investigator assessment ≥ 12 weeks;\n9. Have Eastern Cooperative Oncology Group (ECOG) score ≤ 2;\n10. Have splenomegaly: palpable spleen extending at least 5 cm below the costal margin or unpalpable due to body habitus (obesity), but confirmed to be ≥450 cm³ by MRI (or computed tomography \\[CT\\] scan) at screening;\n11. Have at least 2 symptoms with an average score ≥3 over the 7-day period prior to randomization or an average total score of ≥10 over the 7-day period prior to randomization using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0;\n12. Have bone marrow blast cells ≤10% and peripheral blood blast cells ≤10%;\n13. Have PLT ≥50 × 109 \u002FL and absolute neutrophil count (ANC) ≥ 1.0 × 109 \u002FL and hemoglobin (HGB) \\>60 g\u002FL without the assistance of CSF, EPO, TPO, or component blood transfusions. Have discontinued growth factors and platelets transfusions for more than 2 weeks before screening tests;\n14. Have no overt significant disease involving heart, lungs, liver, kidneys, or pancreas (left ventricular ejection fraction ≥ 45%; serum direct bilirubin ≤2 × upper limit of normal \\[ULN\\]; serum creatinine ≤1.5 × ULN or Estimated Glomerular Filtration Rate \\[eGFR\\] by the 2021 chronic kidney disease-Epidemiology Collaboration formula ≥ 45 mL\u002Fmin\u002F1.73 m2; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] ≤2.5 × ULN) or ≤5 × ULN if associated with liver MF involvement;\n15. Have no severe coagulation dysfunction (prothrombin time \\[PT\\] or thrombin time \\[TT\\] ≤2 × ULN; activated partial thromboplastin time \\[APTT\\] ≤2 × ULN);\n16. Have a normal thiamine level at the time of study entry;\n17. Agree to comply with the relevant regulations of the treating institution and the research organization.\n\nExclusion Criteria:\n\nParticipants must not:\n\n1. Have failure to recover from toxic effects of prior anticancer therapy to Grade 1 or below (except alopecia), or failure to fully recover from prior surgery (major surgery within 4 weeks);\n2. Have known hypersensitivity to the investigational product or its excipients;\n3. Have any significant clinical or laboratory abnormality that would interfere with accurate safety evaluation on study, including:\n\n   1. Uncontrolled diabetes with fasting blood glucose \\>250 mg\u002FdL (13.9 mmol\u002FL);\n   2. Hypertension not controlled by one or two antihypertensive drugs to the following range: systolic \\\u003C160 mmHg, diastolic \\\u003C100 mmHg;\n   3. Peripheral neuropathy of Grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0;\n   4. Thyroid dysfunction of Grade 2 or higher per CTCAE v6.0;\n   5. Any other relevant abnormality in the opinion of the investigator;\n4. Have a history of congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within the 6 months prior to screening;\n5. Have impaired cardiac function including any of the following conditions as determined by echocardiogram or electrocardiogram (ECG): left ventricular ejection fraction less than 45%, or complete left bundle branch block with ST-segment depression greater than 1 mm or T-wave inversion across 2 or more leads. Other criteria include congenital ventricular arrhythmias, clinically significant tachycardia (greater than 100 beats per minute), bradycardia (less than 50 beats per minute) with accompanying clinical symptoms, heart rate less than 60 beats per minute with symptoms, an ECG Corrected QT Interval (QTc) interval greater than 450 ms, or clinically significant cardiac conditions such as unstable angina, congestive heart failure, or myocardial infarction occurring within the last 6 months. Patients with heart failure who meet New York Heart Association class III and IV definitions are ineligible for this study;\n6. Have an active serious infection requiring treatment at the time of screening;\n7. Have undergone splenectomy or who have received splenic irradiation within 6 months prior to screening;\n8. Have Human Immunodeficiency Virus (HIV) positive, active Hepatitis B (Hepatitis B Surface Antigen \\[HBsAg\\] positive and Hepatitis B Virus \\[HBV\\]-DNA ≥1000 copies\u002FmL), or positive for Hepatitis C Virus (HCV) antibodies or HCV-RNA at screening;\n9. Have epilepsy or are taking psychotropic or sedative medications at screening;\n10. Be women of childbearing potential (WOCBP): who are unwilling or unable to practice highly effective contraception before the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    i) Stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles before screening; ii) Intrauterine device; intrauterine hormone-releasing system; iii) Sexual abstinence; iv) Intercourse with a vasectomized partner (the male vasectomized partner is the sole sexual partner of the WOCBP study patient, the vasectomized partner has obtained medical assessment of surgical success for the procedure);\n11. Be sexually active male patients with WOCBP partners who are unwilling to use 1 of the following forms of medically acceptable birth control at the start of the first treatment, during the study, and for at least 6 months after the last dose:\n\n    i) Vasectomy with medical assessment of surgical success or consistent use of a condom; ii) Male Participants must also agree not to donate sperm while receiving the investigational product and for at least 6 months after the last dose;\n12. Have a history of malignancy within the 3 years prior to study screening (except for successfully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);\n13. Have any other severe illnesses that the investigator feels may jeopardize Participant safety or compliance;\n14. Have participated in an investigational agent or medical device study within 1 month prior to screening;\n15. Have prior or concomitant treatment with any of the following: any myelofibrosis therapy (except hydroxyurea that may be stopped one day before first dose; prior JAKi is allowed with a ≥14 day washout); any immunomodulators (e.g., thalidomide); any immunosuppressants; androgenic steroids systemic corticosteroids ≥10 mg\u002Fday prednisone equivalent; or any growth factor (e.g., EPO) within 5 half lives or 2 weeks before enrollment (whichever is longer);\n16. Have received potent or moderate cytochrome P450 (CYP)3A4 inhibitors (including but not limited to ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin) or potent CYP3A4 inducers (including but not limited to rifampin and St. John's wort) within 2 weeks before the first dose;\n17. Have received concomitant QT-prolonging medications that cannot be discontinued or appropriately managed in accordance with the QTc Monitoring Plan;\n18. Have received concomitant strong inhibitors\u002Finducers of P-gp or Breast Cancer Resistance Protein (BCRP)；\n19. Have congenital or acquired bleeding disorders;\n20. Be alcohol dependent or drug abusers;\n21. Consume grapefruit, starfruit, or their products within 48 hours of the first dose of study medication, or be unwilling to abstain from such products while on study as these substances may affect drug absorption, distribution, metabolism, or excretion;\n22. Have any other severe and\u002For uncontrolled concomitant medical condition that in the opinion of the investigator could compromise participation in the study or analysis of study data.\n\n    \\-",{"count":83,"type":21},105,[24],"The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are:\n\nWhich dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis.\n\nParticipants will:\n\nTake Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis.\n\nVisit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study.\n\nVisit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy.\n\nKeep a diary of their symptoms.",[28,57,87,88,89,90,91,92,55,93,94,95],"Myelofibrosis Transformation in Essential Thrombocythemia","Myelofibrosis With High Molecular Risk Mutations","Myelofibrosis With Myeloid Metaplasia","Myelofibrosis, Post ET","Myelofibrosis, Post PV","Myelofibrosis, Primary","Myelofibrosis，MF","Myelofibrosis (PMF)","Myeloid Metaplasia",[97],"Myelofibrosis. JAK inhibitor therapy. De-novo diagnosis. Prior JAK inhibitor therapy. Novel JAK inhibitor. JAK2. FLT3. CDK6.","NOT_YET_RECRUITING","2026-08-05",{"date":64,"type":33},{"date":102,"type":21},"2026-11",{"date":104,"type":21},"2028-11",{"name":106,"class":73},"Chengdu Zenitar Biomedical Technology Co., Ltd",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":116,"type":21},324,[118],"PHASE3","The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[28,56],[122,123],"TAK-226","Drug therapy","2026-08-04",{"date":99,"type":33},{"date":127,"type":21},"2026-08-25",{"date":129,"type":21},"2034-03-30",{"name":131,"class":73},"Takeda",194,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100631248","phase-4-comparing-momelotinib-and-ruxolitinib-in-people-with-untreated-myelofibrosis-and-low-blood-cell-counts-100631248","NCT07498205","Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts","A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis","APEX-MF","Registration Step 1: Randomization\n\nInclusion Criteria:\n\n* Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.\n* Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.\n* Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.\n* Participants must have blasts \\\u003C10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be \\\u003C10% as well.\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must be ≥ 18 years old at the time of registration.\n* Participants must have Zubrod\u002FECOG Performance Status of 0-2.\n* Participants must have a complete medical history and physical exam within 28 days prior to Step 1 registration.\n* Participants must meet hematologic parameters within 28 days prior to Step 1 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 1 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.\n* Participants must be able to take orally administered medication and comply with the oral regimen.\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at Step 1 registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to Step 1 registration.\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants must be offered the opportunity to participate in specimen banking.\n* Participants who can complete PRO and QOL questionnaires in English or Spanish languages must agree to participate in the patient-reported outcomes and quality of life questionnaires.\n* Participants or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and WCG IRB regulations.\n\nExclusion Criteria:\n\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.\n* Participants must not have received prior JAK or ACVR1 inhibitor treatment.\n* Participants must not have received investigational therapy within 14 days prior to Step 1 registration.\n* Participants must not have had a prior splenectomy.\n* Participants must not have had splenic irradiation within 90 days prior to Step 1 registration.\n* Participants must not have received prior chemotherapy for their MF (e.g., hypomethylating agent, hypomethylating agent + venetoclax).\n* Participants must not have had major surgery within 21 days prior to Step 1 registration.\n* Participants must not have received a live vaccine within 14 days prior to Step 1 registration.\n* Participants must not have grade 2 or higher peripheral neuropathy.\n* Participants must not have clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; or unstable angina pectoris. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n* Participants must not have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants must not have history of stroke, reversible ischemic neurologic deficit, or transient ischemic attack within 90 days prior to Step 1 registration.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Participants with curatively treated basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical cancer and\u002For in situ breast cancer may be enrolled.\n* Participants must not have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator.\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n\nRegistration Step 2: Optional Crossover for All Participants after Week 24 Assessment\n\nInclusion Criteria:\n\n* Participants must have met one or more of the following criteria on Registration Step 1:\n\n  1. Spleen volume decrease \\\u003C10% or spleen volume increase of any volume from baseline MRI (or CT) in response to initial treatment (momelotinib or ruxolitinib) from baseline MRI (or CT) at week 24.\n  2. ≥ 3 units of RBC transfusions during any rolling 8-week period starting at or after week 16 preceding Step 2 registration OR hemoglobin \\\u003C 8 g\u002FdL on two consecutive measurements at least 1 week apart during any rolling 8-week period starting at or after week 16 preceding Step 2 registration.\n  3. Unacceptable toxicities attributed to initial treatment (momelotinib or ruxolitinib) of grade ≥ 3 (or grade \\\u003C 3 if determined clinically significant by treating physician) as determined by treating physician.\n  4. Unable to maintain total daily ruxolitinib dose ≥ 20 mg due to cytopenias or intolerance (crossover to momelotinib only).\n* Participants must be able to safely receive the crossover drug (either momelotinib or ruxolitinib) in the opinion of the treating investigator.\n* Participants must have adequate organ and marrow function within 14 days prior to Step 2 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to Step 2 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.",{"count":142,"type":21},268,[144],"PHASE4","The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.",[28,147],"Myelofibrosis (MF)",[28,149,150],"momelotinib","ruxolitinib","2026-08-03",{"date":99,"type":33},{"date":154,"type":21},"2026-08-08",{"date":156,"type":21},"2031-08-08",{"name":158,"class":159},"SWOG Cancer Research Network","NETWORK",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100376029","phase-1-a-study-of-oral-nuvisertib-tp-3654-in-patients-with-myelofibrosis-100376029","NCT04176198","A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis","A Phase 1\u002F2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis","Patients must meet all of the following inclusion criteria to be eligible:\n\nNuvisertib (TP-3654) Monotherapy Arm:\n\n* Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF\u002Fpost-ET- MF and intermediate or high-risk primary or secondary MF\n* Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor\n* Fulfill the following clinical laboratory parameters:\n* Platelet count ≥ 25 x 10\\^9 \u002FL, without assistance of growth factors or platelet transfusions\n* ANC ≥ 1 x 10\\^9\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5%\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI or CT scan) within 2 weeks prior to Cycle 1 Day 1.\n* Dose escalation: At least 2 symptoms measurable (score ≥ 1) using the MF-SAF\n* Dose expansion: At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF\n\nNuvisertib (TP-3654) + Ruxolitinib Arm:\n\n* Confirmed pathological diagnosis of PMF or post-PV-MF\u002Fpost ET- MF and intermediate or high-risk primary or secondary MF\n* On ruxolitinib treatment for ≥ 6 months, and on a stable dose of ruxolitinib (5 to 25 mg BID) for ≥ 8 weeks prior to the first dose of nuvisertib, but has either lost response or had a suboptimal or plateau in response\n* Fulfills the following clinical laboratory parameters:\n* Platelet count ≥ 50 × 10\\^9\u002FL (without assistance of growth factors or platelet transfusions)\n* ANC ≥ 1 × 109\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5% at screening\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI\u002FCT scan) within 2 weeks prior to Cycle 1 Day 1\n* At least 2 symptoms measurable with each score ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n\nNuvisertib (TP-3654) + Momelotinib Arm\n\n* Confirmed pathological diagnosis of PMF or post-PV-MF\u002Fpost ET-MF and intermediate or high-risk primary or secondary MF\n* Previously treated with an approved JAK inhibitor (except momelotinib) for PMF or Post-PV\u002FET MF for ≥ 12 weeks, or ≥ 4 weeks if JAK inhibitor therapy was complicated by a transfusion requirement of ≥ 4 units of red blood cells in 8 weeks, or Grade 3\u002F4 AEs of thrombocytopenia, anemia, or hematoma\n* Fulfills the following clinical laboratory parameters:\n* Anemic, defined as Hb \\\u003C10 g\u002FdL or requiring RBC transfusion at baseline\n* Platelet count ≥ 50 × 109\u002FL (without assistance of growth factors or platelet transfusions)\n* ANC ≥ 1 × 109\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5% at screening\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI\u002FCT scan) within 2 weeks prior to Cycle 1 Day 1\n* At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n\nPatients meeting any one of these exclusion criteria will be prohibited from participating in this study:\n\nNuvisertib (TP-3654) Monotherapy Arm:\n\n* Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For not recovered adequately from from surgery prior to first dose.\n* Splenic irradiation within 6 months prior to Screening or prior splenectomy.\n* Prior allogeneic stem cell transplant within the last 6 months.\n* Eligible for allogeneic bone marrow or stem cell transplantation.\n* Unresolved Grade ≥ 2 non-hematological toxicity related to prior treatment\n* History of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) \\\u003C 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.\n* Corrected QT interval \\> 480msec.\n* Prior or concurrent malignancy that could interfere with the investigational regime.\n* Known history of chronic liver disease, e.g. portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 1 week prior to Cycle 1 Day 1.\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Exhibited allergic reactions or sensitivity to nuvisertib, or similar compound.\n* Medical condition or GI tract surgery that could impair absorption or result in short bowel syndrome with diarrhea.\n* Systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.\n* Pregnant or breastfeeding\n* Currently receiving any other investigational agent.\n\nNuvisertib (TP-3654) + Ruxolitinib Arm:\n\n* Received previous systemic antineoplastic therapy (other than ruxolitinib) or any other experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Note: Prior treatment with nuvisertib is not allowed. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Received systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited)\n* Known allergic reactions or sensitivity to nuvisertib, or similar compound.\n* Splenic irradiation within 6 months prior to Screening or prior splenectomy\n* Prior allogeneic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).\n* Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.)\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For have not recovered adequately prior to first dose.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed).\n* Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)\n* History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \\\u003C45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1\n* Corrected QTcF of \\> 480 msec\n* Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention\n* History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding\n* Pregnant or breastfeeding\n\nNuvisertib (TP-3654) + Momelotinib Arm:\n\n* Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Notes: Prior treatment with momelotinib or nuvisertib is not allowed; in patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper; hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Received systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited).\n* Known allergic reactions or sensitivity to nuvisertib, momelotinib, or any structurally similar drug, or to any component of the formulations of either study intervention\n* Splenic irradiation within 6 months prior to screening or prior splenectomy\n* Prior allogenic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).\n* Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible).\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For have not recovered adequately from surgery prior to first dose.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed)\n* Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)\n* Presence of Grade ≥ 2 peripheral neuropathy\n* History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \\\u003C 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1\n* Corrected QTcF of \\> 480 msec\n* Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention\n* History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding\n* Pregnant or breastfeeding",{"count":168,"type":21},240,[52,24],"This study is a Phase 1\u002F2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.",[28],"2026-07-31",{"date":151,"type":33},{"date":175,"type":33},"2019-12-16",{"date":177,"type":21},"2030-04-30",{"name":179,"class":73},"Sumitomo Pharma America, Inc.",90,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":41},"100207190","quantitative-mri-for-myelofibrosis-100207190","NCT01973881","Quantitative MRI for Myelofibrosis","Quantitative MRI for Myelofibrosis - MRI Parameters as Biomarkers for Analyzing Extent of Disease and Measuring Response to Treatment","Inclusion Criteria:\n\n1. Male \u002Ffemale subjects over the age of 18\n2. Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.\n3. No contraindications to MRI\n4. Able to undergo MRI without anesthesia\n\n   \\-\n\nExclusion Criteria:\n\n1. Patients with pacemakers or other implanted magnetic devices that may malfunction or move because of the strong magnetic field inside the MRI room and scanner.\n2. Any prior adverse event associated with MRI that is not related to injection of contrast agents or other medicines.\n\n   \\-","99 Years",{"count":190,"type":21},192,"OBSERVATIONAL","This study is for the development and validation of functional magnetic resonance imaging (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to treatment in patients with myelofibrosis.",[28],"2026-07-29",{"date":172,"type":33},{"date":197,"type":33},"2014-12-22",{"date":199,"type":21},"2026-12",{"name":201,"class":40},"University of Michigan Rogel Cancer Center",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":209,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",true,{"count":211,"type":21},46,[52],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[215,216,217,218,219,220,221,222,223,28,62,224],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Lymphocytic Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Non-Hodgkin Lymphoma","2026-07-27",{"date":227,"type":33},"2026-07-28",{"date":229,"type":33},"2026-05-08",{"date":231,"type":21},"2029-05-30",{"name":233,"class":40},"City of Hope Medical Center",3,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100575508","phase-1-a-study-of-ruxolitinib-in-combination-with-ulixertinib-in-people-with-myelofibrosis-100575508","NCT06773195","A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis","A Phase 1\u002F2 Study of Combined JAK\u002FERK Inhibition in Patients With Myelofibrosis","Inclusion Criteria:\n\n* Patients with a diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016 criteria.\n* Age ≥18 years.\n* Receiving ruxolitinib monotherapy for at least 3 months with stable dose (10 mg BID to 20mg BID) for at least 4 weeks before first dose of study drug. Note: stable ruxolitinib dosing should be achieved according to strict adherence to dose modification\u002Freduction guidelines detailed in the ruxolitinib package insert, for patients with renal impairment, and\u002For hepatic impairment.\n* Must have DIPSS+ intermediate 2 or greater risk disease, or MIPSS70+ intermediate or greater risk disease\n* Persistent disease despite ruxolitinib monotherapy, as demonstrated by:\n\n  o Grade 2 or 3 reticulin\u002Fcollagen fibrosis on bone marrow AND\n  * Splenomegaly (palpable at least 5cm below subcostal margin\u002For spleen volume \\> 450cm\\^3) OR\n  * Active symptoms (MPN-SAF TSS score \\>10 with at least one MPNSAF TSS score \\>5 or two scores \\>3)\n* ECOG performance status ≤2\n* Participants must have adequate organ and marrow function as defined below unless the elevated laboratory values are attributable to Gilbert's Syndrome with Sponsor review and approval:\n\n  * Absolute neutrophil count ≥ 0.5 K\u002FmcL\n  * Platelets ≥ 50 K\u002FmcL\n  * Direct bilirubin ≤ 1.5 times institutional upper limit of normal (ULN)\n  * Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Creatinine clearance ≥ 50 mL\u002Fmin as calculated by institutional standard\n  * Bone marrow and peripheral blood blast count \\\u003C10%\n* Agreeable to the use of adequate contraception to avoid pregnancy (Appendix D). Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth contro) prior to study entry, for the duration of study participation, and 4 months after completion of drug administration (Appendix D). At least two highly effective methods of contraception, one of which must be a barrier method, are required for males and females of childbearing age during dosing and for 4 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of drug administration\n\nExclusion Criteria:\n\n* Use of experimental drug therapy for MF or any other standard drug with the exception of hydroxyurea or ruxolitinib within 2 weeks of starting combination therapy and\u002For lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better. Hydroxyurea may be utilized to control leukocytosis for up to 4 weeks during study\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Unwilling to receive red blood cell transfusion to treat low hemoglobin.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib and ulixertinib.\n* Participants requiring any medications or substances that are strong inhibitors or inducers of 3A4, strong inhibitors of CYP1A2 and CYP2D6, and inhibitors of Pglycoprotein (P-gp). Strong inhibitors or inducers of 3A4, strong inhibitors of CYP1A2 and CYP2D6, and inhibitors of P-gp must be stopped within 14 days (or 5 half-lives) of study commencement. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Participants who are pregnant or breastfeeding.\n* Pregnant women are excluded from this study because ruxolitinib and ulixertinib are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib and ulixertinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib and ulixertinib.\n* Active bacterial, fungal, or viral infection requiring treatment.\n* Participants with chronic Human immunodeficiency virus (HIV) or hepatitis B or C viral infection.\n\n  * HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: testing does not have to be performed during screening unless participant has known or suspected history of HIV.\n  * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Presence of active interstitial lung disease or pneumonitis.\n* History of cardiovascular risk factors:\n\n  * Clinically significant, uncontrolled arrythmias and\u002For conduction abnormalities. Participants with controlled atrial fibrillation \\>30 days prior to study initiation are eligible.\n  * QTc \\> 480 msec using Fredericia formula.\n  * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study entry;\n  * Class II congestive heart failure or greater or ejection fraction ≤50% on baseline echocardiogram.\n  * History of uncontrolled hypertension.\n* A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n* Psychiatric illness\u002Fsocial situations, active drug, alcohol or substance use that would interfere with study compliance.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending study visits; pose a significant risk to the participant; or interfere with interpreting study data.\n* Participants eligible for allogeneic stem cell transplantation in the opinion of the treating physician at the time of enrollment.\n* Inability to comprehend or unwilling to sign the informed consent form.\n* Transformation to accelerated or blast phase disease, including myeloid sarcoma.",{"count":243,"type":21},37,[52,24],"The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.",[28],[248,249,250,251,252,253],"post-ET myelofibrosis","post-PV myelofibrosis,","post-pre-fibrotic myelofibrosis","JAK\u002FMEK inhibition","Ruxolitinib","Ulixertinib",{"date":227,"type":33},{"date":256,"type":33},"2025-01-07",{"date":258,"type":21},"2028-01",{"name":260,"class":40},"Memorial Sloan Kettering Cancer Center",9,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":41},"100649316","phase-1-revumenib-in-patients-with-myelofibrosis-100649316","NCT07734077","Revumenib in Patients With Myelofibrosis","Phase Ib\u002FII Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis","MPN-RC 129","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults ≥ 18 years of age at time of signing the informed consent\n* Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have a pathologically confirmed diagnosis of PMF, post-ET-MF or post-PV-MF as per the WHO diagnostic criteria, with intermediate-1 or higher risk disease by DIPSS (14.1).\n* Criteria for COHORT-1 (Monotherapy): Treated with at least one prior line of JAK inhibitor therapy to which they were refractory\u002Fresistant, lost response, or intolerant, or is not a candidate for approved JAK inhibitor therapy per investigator judgement, and with one or more of the following features of active disease:\n\n  * Spleen palpable ≥ 5 cm below the left costal margin or \\> 450cm3 by MRI\u002FCT\n  * MPN-SAF TSS ≥ 10\n  * Transfusion dependence (requiring at least 6 units of PRBCs in the 12 weeks prior to study enrollment, for a hemoglobin \\\u003C 8.5g\u002FdL in the absence of bleeding or treatment-induced anemia)\n* Criteria for COHORT-2 (Combination therapy): Currently receiving treatment with an approved JAK inhibitor (including ruxolitinib, fedratinib, or momelotinib) with stable dose for at least 12 weeks prior to study enrollment, and with one or more of the following features of active disease:\n* Spleen palpable ≥ 5 cm below the left costal margin or \\> 450cm3 by MRI\u002FCT\n* MPN-SAF TSS ≥ 10\n* Transfusion dependence (requiring at least 6 units of PRBCs in the 12 weeks prior to study enrollment, for a hemoglobin \\\u003C 8.5g\u002FdL in the absence of bleeding or treatment-induced anemia)\n* Adequate organ function as demonstrated by the following within 28 days prior to Cycle 1 Day 1:\n\n  * ALT (SGPT) and\u002For AST (SGOT) \\\u003C 3 × the upper limit of normal (ULN), or \\\u003C 5 × ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH);\n  * Total bilirubin \\\u003C 3 × ULN for age (\\\u003C 4 x ULN for age if attributed to MF related EMH or Gilbert's syndrome)\n  * Creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft Gault formula;\n  * Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN)\n  * Adequate cardiac function defined as ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan\n  * Bone marrow and\u002For peripheral blood blast count \\\u003C 10%;\n  * Absolute neutrophil count (ANC) ≥ 1000 mm3; and\n  * Platelet count ≥ 75 x 109\u002FL at time of enrollment\n* QTcF ≤ 450msec at screening\n* Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia\n* Life expectancy of at least six months\n* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test within 72 hours before the initiation of protocol therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be obtained. Participants are considered to be not of childbearing potential if they are considered to be post-menopausal or surgically sterilized (eg, , hysterectomy, bilateral salpingectomy). Females who have been amenorrheic for at least 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible reason.\n\n  * Females of childbearing potential must be willing to use a highly effective method of contraception from the time of first study intervention dose through the required contraceptive period (4 months following the last dose of study drug) and must be willing to refrain from in vitro fertilization and egg donation during the required contraceptive period.\n  * Males must be surgically sterile or agree to use barrier contraception (male condoms) from the time of first study intervention dose through the required contraceptive period of 4 months after last dose of study drug. Males must be willing to refrain from sperm donation during the required contraceptive period.\n* Able to adhere to the study visit schedule and all protocol requirements Exclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Treatment with any MF-directed therapy (including investigational therapies) within 2 weeks or 5 half-lives, whichever is shorter, of Cycle 1 Day 1\n\n  * Participants in COHORT-1 should not have received a JAK inhibitor within 14 days prior to Cycle 1 Day 1. Participants who remain on JAK inhibitor at time of screening should be tapered off per investigator discretion.\n  * Hydroxyurea is permitted until the day prior to C1D1, if needed for disease control.\n* Undergone allogeneic hematopoietic stem cell transplant (allo-HSCT) within the last 6 months prior to enrollment, or with active GVHD and\u002For on immunosuppressive therapy.\n* Not currently a candidate for allo-HSCT, per investigator discretion. Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.\n* Prior splenectomy, splenic irradiation, or splenic artery embolization within 6 months of C1D1\n* GI disease meeting any of the following criteria:\n\n  * Impairment of GI function that could significantly alter the absorption of revumenib (eg. Gastric bypass, gastroparesis)\n  * Cirrhosis with a Child-Pugh score of B or C, or National Cancer Institute (NCI) Organ Dysfunction Working Group category of Severe Dysfunction\n  * Inability to swallow oral medications\n* Any of the following cardiac abnormalities:\n\n  * Any of the following within the 6 months before study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident or transient ischemic attack. Participants with controlled atrial fibrillation are allowed to enroll\n  * QTcF (Fridericia's correction) \\> 450ms at screening\n  * Diagnosis of suspicion of Long QT syndrome or family history of Long QT syndrome\n* Recipient of organ transplant\n* Other malignancy within the last three years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated non-metastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial\u002Fnon-invasive transitional cell bladder carcinoma.\n* Presence of uncontrolled active infection of any type. Mild to moderate localized infections under control with antibiotic treatment are acceptable for study entry. Patients with ongoing serious infection are not eligible regardless of antimicrobial therapy. Prophylactic antibiotics are acceptable per NCCN infection guidelines.\n* If participant is known to be human immunodeficiency virus (HIV)-positive, they must have an undetectable HIV viral load within the previous 6 months. If viral load testing has not been performed within the previous 6 months, it much be performed during screening.\n* Known active or chronic hepatitis B, or active hepatitis C infection. Participants with a history of HCV infection who have completed curative therapy for HCV at least 12 weeks before the Screening Visit and have a documented undetectable viral load at the Screening Visit are eligible for inclusion.\n* The following exclusions apply related to concomitant use of CYP3A4 inhibitors and inducers:\n\n  * Participants who will not receive revumenib with coadministration of a strong CYP3A4i (eg, itraconazole, ketoconazole, posaconazole, or voriconazole) must discontinue all strong CYP3A4 inhibitors at least 7 days or 5 half-lives, whichever is longer, before the first dose of revumenib. They will receive goal dose of revumenib 270 mg Q12h and they may continue to receive moderate or weak CYP3A4 inhibitors, including fluconazole and isavuconazole.\n  * Participants who will receive revumenib with coadministration of a strong CYP3A4i (eg, itraconazole, ketoconazole, posaconazole, or voriconazole) must have started the treatment at least 24 hours before the first dose of revumenib. They will receive goal dose of revumenib 160 mg Q12h.\n  * Concomitant use of a strong or moderate CYP3A4 inducer is prohibited while on study. Strong or moderate inducers of CYP3A4 should be discontinued at least five half-lives or 14 days (whichever is longer) prior to the first dose of revumenib.\n* Participants requiring the concurrent use of medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard supportive therapies (eg, diphenhydramine, famotidine, ondansetron, sulfamethoxazole and trimethoprim) and the azoles permitted. Females who are pregnant or lactating.\n* Any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities and inability to swallow pills, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant.",{"count":271,"type":21},32,[52,24],"This is a Phase Ib\u002FII 2 study investigating the safety and efficacy of revumenib in two cohorts of participants with myelofibrosis. COHORT-1 will investigate the safety of revumenib as monotherapy in participants with myelofibrosis previously treated with a JAK inhibitor. Following confirmation of safety in COHORT-1, the study will proceed with enrollment in COHORT-2, which will evaluate the efficacy and safety of revumenib in combination with a JAK inhibitor.",[28,275,59],"Post-polycythemia Vera Myelofibrosis",[28,277,278],"Revumenib","JAK inhibitor","2026-07-24",{"date":194,"type":33},{"date":282,"type":21},"2026-12-01",{"date":284,"type":21},"2028-12-01",{"name":286,"class":40},"John Mascarenhas",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":234},"100612212","phase-1-a-study-of-rebecsinib-for-patients-with-relapsedrefractory-secondary-acute-myeloid-leukemia-or-high-risk-myelofibrosis-100612212","NCT07250646","A Study of Rebecsinib for Patients With Relapsed\u002FRefractory Secondary Acute Myeloid Leukemia or High Risk Myelofibrosis","A Phase 1 Study of Rebecsinib, a Spliceosome Modulator That Inhibits ADAR1, in Patients With Relapsed or Refractory Secondary Acute Myeloid Leukemia or Higher-Risk Myelofibrosis","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent.\n2. Must have a refractory myeloid neoplasm (5th Edition WHO Classification of Tumors) consisting of secondary AML (sAML), which has evolved from antecedent MDS, MPN, MDS\u002FMPN, or have higher-risk MF defined by DIPSS Plus or MIPSS70+ version 2.0, and excess bone marrow blasts (\\> 5%). Patients with sAML, defined as AML with an antecedent history of MDS or MPN or WHO AML with myelodysplasia related genetic changes or WHO AML with myelodysplasia related cytogenetic abnormalities. Must be ineligible for bone marrow transplantation at the time of enrollment and have relapsed or be refractory or intolerant to available therapies, such as anthracycline chemotherapy, epigenetic modifier therapy (azacytidine or decitabine) or venetoclax including any treatment that is active in specific mutations if relevant (e.g., FLT3 inhibitors for patients with FLT3 mutations). If the patient has not received intensive induction chemotherapy in the past as a result of being unfit for chemotherapy, then the patient must have undergone at least one line of epigenetic modifier or other available therapy. If the patient has received intensive induction therapy, then the patient must have undergone at least two lines of therapy. If a patient has a FLT3 or IDH mutation, prior therapy must include a FLT3 or an IDH inhibitor. Relapse is defined as the recurrence of excess leukemic blasts in the marrow after previously achieving a complete remission, or complete remission with incomplete count recovery. Refractory refers to persistent excess leukemic blasts after two cycles of standard anthracycline containing induction, or one cycle of a high dose cytarabine containing regimen, or one cycle of a non-intensive regimen.\n3. Calculated Creatinine clearance (CrCl) \\> 60 mL\u002Fmin (based upon the Cockcroft- Gault Equation \\[CrCl = (140-age) \\* ideal body wt (in kg) \\* (0.85 if female) \u002F (72 \\* Cr)\\]. Estimate Ideal body weight in (kg) Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet. Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet.\n4. Has recovered from the toxic effects of prior therapy to their clinical baseline.\n5. Subjects must be aged 18 years or older.\n6. Both men and women of all races and ethnic groups are eligible for this trial.\n7. Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of rebecsinib.\n8. Women of child-bearing potentialmust have a negative serum or urine pregnancy test.\n9. For sAML and high risk MF, at relapse must have ≥5% leukemic bone marrow blasts.\n10. Subjects must have an ECOG performance status of 0-2.\n11. Hemoglobin ≥ 8.0 g\u002FdL. This is to alleviate immediate concomitant need for transfusion via institutional guidelines for transfusion for symptomatic anemia.\n12. Total bilirubin ≤ 1.5 times upper limit of normal.\n13. ALT and AST ≤ 1.5 times upper limit of normal\n14. Prothrombin time international normalized ratio (INR) ≤ 2; AND Partial thromboplastin time ≤ 1.66 times upper limit of normal.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding females are excluded.\n2. Previous hematopoietic cell transplant.\n3. Patients who are currently receiving another investigational agent are excluded.\n4. Patients who have had chemotherapy (e.g., HMA therapy, chemotherapy, immunotherapy) or participation in any investigational drug treatment within 2 weeks or 5-half lives, whichever is more, of initiation of rebecsinib or at any time during the study.\n5. Current infection requiring systemic antibiotics.\n6. Active infection with HIV, HBV, or HCV.\n7. Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ or localized non-melanoma skin cancer).\n8. Known central nervous system (CNS) involvement by malignancy.\n9. Untreated autoimmunity such as autoimmune hemolytic anemia or immune thrombocytopenia.\n10. Known uncompensated hypothyroidism (defined as TSH greater than 2x upper limit of normal not treated with replacement hormone).\n11. Insufficient recovery from surgery-related wound healing.\n12. Impaired cardiac function including any of the following:\n\n    1. Myocardial infarction within 6 months of starting study drug;\n    2. A past medical history of clinically significant ECG abnormalities, including QTc 470 msec or greater.\n    3. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)\n13. A QT -\\>470 msec on ECG.\n14. On medication that is an inducer or inhibitor of CYP3A4, CYP2C9, CYP2C19, CYP2B6 and hepatic uptake transporters (e.g. OATP1B1\u002F3, OAT1\u002F2 OCT 1\u002F2), or is metabolized by CYP2C9, 2C19, and 2B6. If they are an inducer or inhibitor or a known substrate of CYP2B6, CYP2C9, and CYP2C19 where minimal changes in drug concentration may lead to serious adverse reactions, the drug should be withdrawn for a minimum of 5 half lives or particular attention should be paid to toxicities or appropriate dose modifications to these drugs made.\n15. Patients who in the opinion of the investigator may be unable to comply with the safety monitoring requirements of the study.",{"count":295,"type":21},28,[52],"The purpose of this study is to test the safest and most effective dose of a new investigational drug, rebecsinib. Participants in this study will have either Secondary Acute Myeloid Leukemia (sAML) that has either returned (relapsed) or not responded to treatment (refractory) or have higher risk Myelofibrosis (MF). Participants will receive a study drug infusion on Day 1, Day 4, Day 8 and Day 11 of each 28-day cycle for a total of 6 cycles.",[299,28],"Secondary AML",[301,302],"sAML","MF","2026-07-16",{"date":305,"type":33},"2026-07-20",{"date":307,"type":33},"2026-05-21",{"date":309,"type":21},"2028-04",{"name":311,"class":73},"Aspera Biomedicines, Inc.",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100635341","phase-2-a-clinical-trial-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-tq05105-tablets-in-subjects-with-intermediatehigh-risk-myelofibrosis-100635341","NCT07551427","A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","Inclusion Criteria:\n\n1. Voluntary and signed informed consent, good compliance.\n2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.\n3. Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted.\n4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).\n5. Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant.\n6. Spleen enlargement (except Cohort 1).\n7. Peripheral blood and bone marrow blasts ≤10%.\n8. No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose.\n9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).\n10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.\n\nExclusion Criteria:\n\n1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.\n2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).\n3. Prior splenectomy or splenic radiotherapy within 6 months before first dose.\n4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol).\n5. Factors affecting oral drug absorption.\n6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).\n7. Major surgery or significant traumatic injury within 4 weeks before first dose.\n8. Congenital bleeding or coagulation disorders.\n9. Arterial\u002Fvenous thrombosis event within 6 months before first dose.\n10. History of substance abuse or mental disorder.\n11. Active or uncontrolled severe infection.\n12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.\n14. Uncontrolled hypertension despite standard therapy.\n15. Renal failure requiring hemodialysis or peritoneal dialysis.\n16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.\n17. History of immunodeficiency or organ transplantation.\n18. Epilepsy requiring treatment.\n19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.\n20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.\n21. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n22. Live attenuated vaccine within 4 weeks before first dose or planned during the study.\n23. Known hypersensitivity to study drug or excipients.\n24. Diagnosis of active autoimmune disease within 2 years before first dose.\n25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.\n26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.",{"count":320,"type":21},51,[24],"This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate\u002Fhigh-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.",[28],"2026-07-14",{"date":326,"type":33},"2026-07-15",{"date":328,"type":33},"2026-06-18",{"date":330,"type":21},"2029-06",{"name":332,"class":73},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",24,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100557107","clinical-epidemiology-in-contemporary-patients-with-myelofibrosis-100557107","NCT06533813","Clinical Epidemiology in Contemporary Patients With Myelofibrosis.","Clinical Epidemiology in Contemporary Patients With Myelofibrosis (ERNEST-3): A European LeukemiaNet (ELN) Observational Study","ERNEST-3","Inclusion Criteria:\n\n* Diagnosis of primary myelofibrosis (PMF) or secondary (i.e., post-ET\u002FPV MF) myelofibrosis according to 2016- or 2022-WHO criteria ascertained between 01\u002F01\u002F2018 and 31\u002F12\u002F2027\n* Age ≥ 18 years\n* Signed informed consent where applicable, in line with current European General Data Protection Regulation (GDPR) directives\n\nExclusion Criteria:\n\n* Diagnosis of early\u002Fprefibrotic primary myelofibrosis\n* Concurrent participation to interventional clinical trials in MF","100 Years",{"count":344,"type":21},617,"Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from 01\u002F01\u002F2018 to 31\u002F12\u002F2027 will be enrolled into the study. Yearly follow-up updates will be scheduled until the end of data collection on 31\u002F12\u002F2028 or until the last available patient visit, whichever comes first. At least 1 year of follow-up will be ensured from the last patient enrolled.",[28],"2026-07-08",{"date":349,"type":33},"2026-07-09",{"date":351,"type":33},"2024-10-14",{"date":353,"type":21},"2028-12-31",{"name":355,"class":40},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS",27,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":41},"100633004","phase-1-tolerability-of-ropeginterferon-alfa-2b-add-on-to-ongoing-ruxolitinib-therapy-in-myelofibrosis-roperux-in-myelofibrosis-100633004","NCT07521046","Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)","A Phase 1b Study of Safety, Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.\n* Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.\n* Subjects must have spleen volume of \\> 450ml by either MRI or CT scan\n* Subject must have a JAK2, CALR, or MPL allelic burden of ≥20% at screening\n\n  --Prior treatment for PV or ET with hydroxyurea or ruxolitinib is allowed. If the patient was on pegylated interferon in the past, the progression from PV\u002F ET to post-PV\u002FET MF must not have occurred while on pegylated interferon therapy.\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * WBC count ≥ 4 x 109\u002FL\n    * Absolute neutrophil count (ANC) ≥1500\u002Fmm3\n    * Platelet count ≥ 75,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    ---Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n\n    ---AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula\n* Recovery to baseline or ≤ Grade 1 CTCAE v 6.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.\n* Participants must adhere to the following sex and contraceptive\u002Fbarrier requirements:\n\n  * If participant is of childbearing potential, they must have a negative pregnancy test\n  * For participants of non-childbearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n  * \\\u003C 50 years of age:\n\n    ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n\n    ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n\n    --≥ 50 years of age:\n\n    ---Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n\n    ---Had radiation-induced menopause with last menses \\>1 year ago; or\n\n    ---Had chemotherapy-induced menopause with last menses \\>1 year ago\n\n    ---Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 6.4.1 and 6.4.3.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.\n* Receiving other investigational agents.\n* Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).\n* Evidence of severe retinopathy or clinically significant eye disease.\n* History or presence of active serious or untreated autoimmune disease.\n* History of solid organ transplant.\n* Liver cirrhosis Child-Pugh score B or C. -≥ 5% blasts in peripheral blood or bone marrow.\n* Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* The diagnosis of another malignancy which, in the investigator's opinion, is likely to significantly impact study participation.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Uncontrolled hypertension, in the opinion of the investigator\n    * Congestive heart failure New York Heart Association Class II or greater, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke or myocardial infarction within the past 3 months\n    * Significant coronary stenosis, in the opinion of the investigator\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.\n\nNote: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.\n\n-Active infection requiring systemic therapy, including, but not limited to: tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.\n\nNote: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v 6.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 7.8. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":365,"type":21},15,[52],"The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.",[28],"2026-07-07",{"date":347,"type":33},{"date":372,"type":21},"2026-08",{"date":374,"type":21},"2030-08",{"name":376,"class":40},"University of Utah",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":404,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":41},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.",{"count":385,"type":21},56,[24],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[389,390,391,392,393,394,395,60,396,397,398,399,400,401,402,403,62,28],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Prolymphocytic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Burkitt Lymphoma","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma",[405,406,407,408,409,410,411,412,413,414,415,16],"MDS","CLL","SLL","AML","CML","PFS","TRM","GVHD","MMF","TBI","PTCy","2026-07-02",{"date":418,"type":33},"2026-07-06",{"date":420,"type":33},"2023-05-01",{"date":422,"type":21},"2028-10-22",{"name":424,"class":40},"Masonic Cancer Center, University of Minnesota",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":455,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":41},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":434,"type":21},300,[24],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[438,217,216,439,394,395,440,28,441,442,443,218,401,444,403,445,446,393,447,222,398,448,449,450,451,452,453,454],"Acute Leukemia","Lymphoma","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Diffuse Large Cell Non Hodgkins Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[408,16,405,456,406,409,407],"NHL","2026-06-23",{"date":459,"type":33},"2026-06-25",{"date":461,"type":33},"2018-03-30",{"date":463,"type":21},"2028-06-10",{"name":424,"class":40},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":41},"100591168","research-platform-myelofibrosis-and-anemia-100591168","NCT06976918","Research Platform Myelofibrosis and Anemia","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)","RHODOLITE","Inclusion Criteria:\n\n* Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).\n* Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.\n* Start of first or subsequent systemic treatment for MF.\n* Informed consent and registration for the GSG-MPN Bioregistry.\n* Willingness and capability to participate in PRO assessment.\n* Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for diagnosed primary or secondary MF.\n* Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.",{"count":474,"type":21},200,"The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.",[58,477,275,59,56,55,28],"Secondary Myelofibrosis","2026-06-03",{"date":480,"type":33},"2026-06-05",{"date":482,"type":33},"2026-02-19",{"date":484,"type":21},"2031-09",{"name":486,"class":73},"iOMEDICO AG",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":41},"100480421","phase-1-allohct-with-peginfa-for-myelofibrosis-100480421","NCT05535764","AlloHCT With PegINFa for Myelofibrosis","Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis (ATIOM)","ATIOM","Inclusion Criteria:\n\nPre-Transplant Inclusion Criteria (Step 1)\n\n* Male or female subject aged ≥ 18 years.\n* Diagnosis of primary or secondary myelofibrosis.\n* Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC)\n* Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up.\n* Peripheral blood stem cell (PBSC) graft\n* 10\u002F10 HLA matched related or matched unrelated donor\n* ECOG performance status ≤ 2.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n\nTreatment Inclusion Criteria (Step 2)\n\n* Male or female subject aged ≥ 18 years.\n* Diagnosis of primary or secondary myelofibrosis.\n* Have undergone a myeloablative or reduced-intensity conditioning regimen (MAC or RIC) and be 50-80 days from Day 0 of transplant at initiation of study therapy.\n* Peripheral blood stem cell (PBSC) graft\n* 10\u002F10 HLA matched related or matched unrelated donor\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    ---Estimated creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault formula:\n  * TSH and T4 within normal limits or adequately controlled thyroid function.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Male subjects must agree to use a condom during intercourse for the duration of study therapy as described in Section 5.4.1.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\nExclusion Criteria (Step 2)\n\n* Receiving other investigational agents concurrently\n* Prior systemic anti-cancer therapy or any investigational therapy within five half-lives prior to starting study treatment.\n* Prior radiotherapy within 6 weeks prior to the first dose of study treatment.\n* Major surgery within 6 weeks prior to starting study drug or patients who have not fully recovered from major surgery.\n* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and\u002For will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Graft-versus-host disease:\n\n    ---Acute or chronic\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 140\u002F90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Active infection including HIV, tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice) or hepatitis C.\n\n  --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n* Autoimmune hepatitis or decompensated hepatic disease\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.5.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.\n* History of neuropsychiatric disease, autoimmune disease, or pancreatitis.\n* Presence of active interstitial lung disease or pneumonitis, bronchiolitis obliterans, pulmonary hypertension, ulcerative and hemorrhagic\u002Fischemic colitis, and ophthalmologic disorders.",{"count":496,"type":21},18,[52],"This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.",[28],"2026-06-02",{"date":502,"type":33},"2026-06-04",{"date":504,"type":33},"2023-08-02",{"date":506,"type":21},"2028-03",{"name":376,"class":40},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":518,"conditions":519,"keywords":524,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":41},"100359777","early-phase-1-hyperbaric-oxygen-therapy-and-allogeneic-peripheral-blood-stem-cell-pbsc-transplant-100359777","NCT03964506","Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant","A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem\u002FProgenitor Transplantation","Inclusion Criteria:\n\n* Voluntary written informed consent\n* Men or women, age ≥ 18 years of age, with upper limit of 75 years old.\n* Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.\n* Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic\u002Fmyeloproliferative (MDS\u002FMPN) overlap syndrome for cohort 2.\n* Karnofsky performance status (KPS) of ≥ 70%\n* Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain).\n* Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST \\\u003C 4x IULN and serum total bilirubin ≤ 2.0 mg\u002FdL; Renal: serum creatinine: ≤ 2.0 mg\u002FdL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Severe chronic obstructive pulmonary disease requiring oxygen supplementation\n* History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs\n* Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.\n* Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS\u002FMPN overlap syndrome.\n* Active ear\u002Fsinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.\n* Recent sinus surgery (within the last 5 years).\n* Ear surgery excluding myringotomy or ear tubes\n* Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.\n* Claustrophobia\n* History of recurrent seizures within 5 years of study enrollment.\n* Uncontrolled asthma\n* Uncontrolled viral or bacterial infection at the time of study enrollment\n* Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval\n* Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen",{"count":333,"type":21},[517],"EARLY_PHASE1","The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic\u002Fmyeloproliferative (MDS\u002FMPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.",[217,60,520,521,522,28,523],"Chronic Myelomonocytic Leukemia","Atypical Chronic Myeloid Leukemia","Chronic Monocytic Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm",[525,526],"Allogeneic transplant","Hyperbaric Oxygen","2026-06-01",{"date":478,"type":33},{"date":530,"type":33},"2020-07-01",{"date":532,"type":21},"2028-03-01",{"name":534,"class":40},"Omar Aljitawi",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":545,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":556,"locationsCount":41},"100622092","phase-1-therapeutic-rsk1-targeting-in-myelofibrosis-100622092","NCT07379125","Therapeutic RSK1 Targeting in Myelofibrosis","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis in chronic phase, according to the 2016 WHO criteria\n\n  * Patients must have had at least 1 prior JAK inhibitor treatment for a minimum of 12 weeks and their disease was determined resistant or refractory, and\u002For their response was lost or intolerant to treatment.\n* Intermediate-2 or High-risk MF, as defined by the Dynamic International Prognostic Scoring System (DIPSS).\n* Presence of measurable disease as defined by:\n\n  * Splenomegaly defined as estimated spleen volume of ≥450 cm3 by imaging with either MRI, CT or ultrasound, or a palpable spleen \\>=5 cm from the costal margin.\n  * Baseline MFSAF v4.0 Total Symptom Score ≥ 10\n* At least 18 years of age.\n* ECOG performance status ≤ 2.\n* Adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x IULN (unless the participant has a history of Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault\n* Adequate laboratory parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 100\u002Fmm\\^3\n  * Platelets ≥50,000\u002Fmm\\^3\n  * Blasts ≤ 10% on manual differential\n* The effects of PMD-026 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior allogeneic or autologous stem cell transplantation within the previous 12 months\n* Prior splenectomy\n* Prior splenic irradiation if \\\u003C 3 months between last radiation and screening visit.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents or planning to receive any investigational agents within 28 days before the planned first dose of PMD-026.\n* Currently receiving a JAK inhibitor or planning to receive a JAK inhibitor within 7 days before the planned first dose of PMD-026. In patients with ongoing JAK inhibitor therapy (i.e. ruxolitinib) at screening, it must be tapered over a period of at least 7 days. Patients on a low dose of ruxolitinib (e.g. 5 mg QD) may have a reduced taper period or no taper.\n* Known active disease involving the CNS.\n* QTcF \\>450 msec for males, \\>470 msec for females (calculated using Fridericia's formula).\n* A history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to PMD-026 or other agents used in the study.\n* Any major surgery within 28 days prior to the first dose of PMD-026.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Unable to swallow or retain oral medications.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 35 days of study entry (repeated on C1D1).",{"count":496,"type":21},[52],"This is a phase Ib study evaluating PMD-026, an oral inhibitor of ribosomal protein S6 kinase A1 (RSK1), in participants with myelofibrosis (MF).The dose escalation portion utilizes a standard 3+3 design to evaluate two dose levels with an additional dose de-escalation portion to identify the recommended phase II dose (RP2D); subsequently, an additional 6 patients will be enrolled in the dose expansion portion evaluating the efficacy of PMD-026.",[28],[28,58,477,275,59,27,56,546,547,548,549,550,62],"Spleen volume","Spleen","Hematologic Diseases","Bone Marrow Diseases","Bone Marrow Cancer",{"date":552,"type":33},"2026-05-22",{"date":554,"type":33},"2026-05-20",{"date":353,"type":21},{"name":557,"class":40},"Washington University School of Medicine",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":16,"minAge":566,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":593},"100430719","phase-2-methods-of-t-cell-depletion-trial-motd-100430719","NCT04888741","Methods of T Cell Depletion Trial (MoTD)","A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide","MoTD","Inclusion Criteria:\n\n* Availability of suitably matched unrelated donor (9\u002F10 or 10\u002F10)\n* Planned to receive one of the following RIC protocols:\n\n  * Fludarabine-Melphalan (Fludarabine 120-180mg\u002Fm2 IV; melphalan ≤ 150mg\u002Fm2 IV)\n  * BEAM or LEAM (carmustine 300mg\u002Fm2 IV or lomustine 200mg\u002Fm2 IV with: etoposide 800 mg\u002Fm2 IV; cytarabine 1600mg\u002Fm2 IV; melphalan 140mg\u002Fm2 IV)\n  * Fludarabine-Busulphan (Fludarabine 120-180mg\u002Fm2 IV; Busulphan ≤ 8mg\u002Fkg PO or 6.4mg\u002Fkg IV)\n  * Fludarabine- Treosulfan (Fludarabine 150mg\u002Fm2 IV; Treosulfan 30g\u002Fm2 IV)\n* Planned use of PBSCs for transplantation\n* Planned allo-SCT for one of the following haematological malignancies:\n\n  * AML in CR (patients enrolled onto the COSI trial are not eligible for this study)\n  * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)\n  * CMML \\\u003C10% blasts\n  * MDS \\\u003C10% blasts (patients enrolled onto the COSI trial are not eligible for this study)\n  * NHL in CR\u002FPR\n  * HL in CR\u002FPR\n  * MM in CR\u002FPR\n  * CLL in CR\u002FPR\n  * CML in 1st or 2nd chronic phase\n  * Myelofibrosis\n* Age 16-70 years\n* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nExclusion Criteria:\n\n* Use of any method of graft manipulation (excluding storage of future DLI)\n* Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined\n* Known hypersensitivity to study drugs or history of hypersensitivity to rabbits\n* Pregnant or lactating women\n* Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period\n* Life expectancy \\\u003C8 weeks\n* Active HBV or HCV infection\n* Organ dysfunction defined as:\n\n  * LVEF \\\u003C45%\n  * GFR \\\u003C50ml\u002Fmin\n  * Bilirubin \\>50µmol\u002Fl\n  * AST\u002FALT\\>3 x ULN\n* Participation in COSI or ALL-RIC trials\n* Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.\n* Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.","16 Years","70 Years",{"count":569,"type":21},400,[24],"A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.",[217,216,520,60,573,221,449,394,28],"Non Hodgkin Lymphoma",[575,576,408,405,409,577,456,578,579,580,581,582,583],"GvHD","Allogeneic Stem Cell Transplant","CMML","HL","Cyclophosphamide","Thymoglobulin","Cyclosporin","Sirolimus","Mycophenolate Mofetil","2026-04-29",{"date":586,"type":33},"2026-05-05",{"date":588,"type":33},"2021-02-22",{"date":590,"type":21},"2027-08-23",{"name":592,"class":40},"University of Birmingham",17,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":16,"minAge":601,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":612,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":623},"100421728","phase-1-study-of-oral-administration-of-lp-118-in-patients-with-relapsed-or-refractory-cll-sll-mds-mdsmpn-aml-cmml-2-mpn-bp-all-mf-nhl-rt-mm-or-t-pll-100421728","NCT04771572","Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS\u002FMPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.","A Phase 1\u002F1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years of age at the time of Screening with the following exception as outlined below:\n\n   -For T cell and B cell ALL subjects with age between 13 - 18 years, their body weight shall be ≥ 40 kg.\n2. Eligible subject must have an advanced hematologic malignancy including:\n\n   Group 1:\n\n   Group 1a\n   * Relapsed or refractory low risk tumor lysis CLL\u002FSLL subjects (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.\n   * For CLL\u002FSLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days as these subjects, progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n\n   Group 1b\n   * Morphologically confirmed diagnosis of MF in accordance with the WHO 2016 revised criteria, that is relapsed, intolerant, and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Morphologically confirmed diagnosis of MDS\u002FMPN, excluding juvenile myelomonocytic leukemia (JMML), in accordance with WHO 2016 revised criteria, that is relapsed and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Chronic myelomonocytic leukemia (CMML) with \\\u003C9% blasts;\n   * Or atypical chronic myeloid leukemia (aCML) with Hgb \\> 10g\u002FdL, WBC count \\\u003C 50 x 109 cells\u002FL, \\\u003C10% immature circulating cells;\n   * Or MDS\u002FMPN with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T) with Hgb \\> 10g\u002FdL;\n   * Or myelodysplastic\u002Fmyeloproliferative neoplasm, unclassifiable (MDS\u002FMPN-UC)\n   * CMML-2 with 10-19% blasts as defined by WHO 2016 revised criteria that is relapsed and\u002For refractory to prior HMA therapy;\n   * Relapsed and\u002For refractory MPN-BP as defined by WHO 2016 revised criteria that is transformed MPN with \\>20% myeloid blasts in the peripheral blood or bone marrow, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * MDS subjects with refractory anemia with excess blasts (MDS-EB; subtype MDS-EB-1 or MDS-EB-2) as defined by WHO 2016 revised criteria and\u002For MDS with high- or very high-risk (risk score \\> 4.5) per the Revised International Prognostic Scoring System (IPSS-R, refer to Appendix 11; Section 15.13) who have no available therapies known to provide clinical benefit;\n   * Relapsed or refractory AML subjects (including de novo AML, secondary AML evolving from MDS or MPN or other antecedent hematologic disorder, and therapy-related AML) as defined by WHO 2016 revised criteria, subjects who have no available therapies known to provide clinical benefits; subjects with prior BCL-2 inhibitor therapy are permitted. WBC needs to be ≤ 25 × 109 cells\u002FL at the time of initiating investigational therapy (hydroxyurea is allowed to control WBC prior to and during therapy).\n\n   Group 1c\n   * Relapsed or refractory low risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Low risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Low risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 and have no treatment options available known to provide clinical benefit;\n   * Low risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n\n   Group 1d\n   * Relapsed or refractory ALL with dexamethasone run-in \\[5 days, dexamethasone 10mg\u002Fm2 (divided BID)\\];\n   * Or r\u002Fr ALL in remission but with detectable MRD (MRD +) by any detection method per institution standard of practice;\n   * IT chemo (per institutional SOC) is permitted prior to LP-118 C1D1 dosing, and then concomitantly on treatment if in best interest of the subject;\n   * Relapsed or refractory ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and failed.\n   * Relapsed or refractory ALL subjects with age between 13 - 18 years and have body weight ≥ 40kg, ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and progressed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and progressed.\n\n   Group 2\n   * Relapsed or refractory intermediate and high risk tumor lysis CLL\u002FSLL subjects who have received at least two prior therapies;\n   * Relapsed or refractory intermediate and high risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Intermediate and high risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Intermediate and high risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Intermediate and high risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n3. For Group 1d ALL subjects only, white blood cell (WBC) count ≤ 25 × 109 cells\u002FL at the time of enrollment (glucocorticoids or hydroxyurea is permitted to control WBC count prior to and during therapy).\n4. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.\n5. Adequate cardiac function defined as shortening fraction of ≥ 40% by 2D echocardiogram without Doppler.\n6. Subject must have adequate bone marrow (independent of growth factor support), coagulation, renal, and hepatic function, per laboratory reference ranges at Screening as follows:\n\n   Bone marrow criteria:\n   * Group 1 (r\u002Fr low risk tumor lysis CLL\u002FSLL (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm), NHL, RT, MM, T-PLL):\n   * Absolute Neutrophil Count (ANC) ≥ 1 x 109\u002FL (An exception is for subjects with an ANC\\\u003C1 x 109\u002FL and bone marrow heavily infiltrated with underlying disease)\n   * Platelets ≥ 50 x 109\u002FL on day of screening (entry platelet count must be independent of transfusion with 14 days of screening);\n   * Hemostasis criteria: Activated partial thromboplastin time (APPT) and prothrombin time (PT) ≤ 1.5 × the upper limit of normal (ULN);\n   * Renal function criteria: Serum creatinine ≤ ULN (per local institution reference range) or Calculated creatinine clearance (Cr Cl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR by Cockcroft-Gault formula using actual body weight.\n   * Hepatic function criteria: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n7. Females of childbearing potential (i.e., non-postmenopausal for at least 2 years or surgically sterile) and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 90 days after discontinuing study drug:\n\n   * Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable;\n   * Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy;\n   * Intrauterine device;\n   * Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) associated with inhibition of ovulation initiated for at least 1 month prior to study drug administration.\n8. Females of childbearing potential must have a negative pregnancy result as follows:\n\n   * At Screening on a serum sample obtained within 7 days prior to the first study drug administration, and\n   * Prior to dosing on a urine or serum sample obtained on the first day of study drug administration if ithas been \\> 7 days since obtaining the serum pregnancy test results in Screening.\n   * If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation\n9. Male subjects must refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug.\n10. Subject must be able to understand and voluntarily sign and date an informed consent form (ICF), approved by an IRB, prior to any protocol-related procedures.\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n1. Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-118, or subjects on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n2. Subject has a history of other malignancies within past 12 months that are active and could result in competing risks. These cases shall be discussed with the Medical Monitor with the exception below.\n\n   * Subject with breast cancer or prostate cancer on endocrine therapy with stable disease;\n   * Continuation of maintenance therapy in patients with adequately treated malignancy\n   * Adequately treated in situ carcinoma of the cervix uteri;\n   * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n   * Cancer with expected survival of 2 years or more or that will not confound evaluation of LP-118 treatment\n3. Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of LP-118, or has not recovered to ≤ Grade 2 clinically significant AEs of the previous therapy (excluding neuropathy):\n\n   * Any anti-neoplastic therapy including chemotherapy, hormonal therapy, radiotherapy, biologic or immunotherapy, targeted small molecule agents, etc. (corticosteroid therapy \\\u003C 20 mg\u002Fday prednisone equivalent according to institutional guidelines to treat disease associated symptoms are permitted);\n   * For MF subjects who come off JAK2 antagonists, allow washout for 2 days as these subject's progress quickly after treatment discontinuation and remain eligible (steroids may be given during these two days to allow disease control).\n   * Subjects in need of immediate cytoreduction should be excluded.\n   * Any investigational therapy.\n   * Live vaccines\n4. Subject has received the following medications, therapies, or natural products within 7 days prior to the first dose of LP-118:\n\n   * Cytochrome P450, family 3, subfamily A (CYP3A) strong inhibitors (itraconazole, etc.), or substrates (Appendix 19);\n   * Subject has received strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers within 14 days prior to the first dose of LP-118 (Appendix 19);\n   * Grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit;\n   * There is a 28-day washout period required for subjects who have had prior CAR-T treatment if there is no evidence of cytokine release syndrome (CRS) or other adverse events related to the CAR-T treatment, per discussion with the Medical Monitor.\n5. Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect his\u002Fher participation in this study. Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the study, place the subject at unacceptable risk or interfere with the interpretation of the results. For subjects who have required surgical intervention for any above diseases within the past 6 months, a discussion with the Investigator and the Medical Monitor is needed.\n6. Subject has baseline prolongation of the heart rate-corrected QT (QTcF) interval ≥ 480 ms (calculated per Fridericia's formula \\[QTcF = QT\u002FRR (1\u002F3)\\])), a cardiovascular disability status of New York Heart Association Class ≥ 2 or associated other significant screening ECG or ultrasonic cardiogram abnormalities, per Investigator's judgement. For any subject with underlying RBBB or LBBB, cardiology review is needed to correct QTcF calculation using Sponsor recommended formula.\n7. Subject has significant a history of congenital long QT syndrome or Torsades de Pointes (TdP), uncontrolled or symptomatic arrhythmias, congestive heart failure, myocardial infarction, stroke, or intracranial hemorrhage within 6 months prior to the first dose of LP-118.\n8. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   * Uncontrolled active systemic infection (bacterial, fungal, viral);\n   * Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HbsAg positive, or HbcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive);\n   * Unexplained fever \\> 38.5°C within 7 days prior to the first dose of study drug administration (at the discretion of the Investigator if the fever is considered attributed to the subject's malignancy or an explained infection may be enrolled).\n9. A female subject is pregnant or breast-feeding.\n10. Subject incapacity to swallow oral medications, with any malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that, in the opinion of the Investigator, may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally.\n11. Subjects with known and active central nervous system (CNS) involvement at Screening.\n12. Subjects with known hypersensitivity to any of the components of LP-118 (see Investigators Brochure for a list of components).\n13. Subjects who are taking QT-prolonging drugs that are known to cause Torsades de Pointes (TdP) (See Appendix 17 for the list of medications that are associated with TdP). In the event a prohibited medication might cause TdP, the PI must first determine if the risk to benefit is in favor of the subject and then discuss with the Medical Monitor about that particular medication on a case-by-case basis.\n14. Major surgery within 14 days prior to the first dose of study drug.","13 Years",{"count":603,"type":21},100,[52],"This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.",[573,607,449,608,217,390,609,523,28,218,401,610,611],"Richter Transformation","T-cell-prolymphocytic Leukemia","Myeodysplastic Syndrome","Chronic Myelomonocytic Leukemia-2","Myelodysplastic Neoplasm in Blast Phase",[613,614,615],"Hematological Malignancies","Relapsed","Refractory",{"date":586,"type":33},{"date":618,"type":33},"2022-05-08",{"date":620,"type":21},"2027-12-31",{"name":622,"class":73},"Newave Pharmaceutical Inc",8,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":643,"locationsCount":41},"100614606","phase-1-treating-anemia-in-myelofibrosis-with-repurposed-drugs-nelfinavir-that-restore-iron-delivery-to-the-bone-marrow-100614606","NCT07281781","Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow","Inclusion Criteria:\n\n* ≥18 years of age\n* Have a diagnosis of myelofibrosis (MF) according to the 2016 WHO criteria\n* Has a hemoglobin ≤ 10gm\u002FdL at screening\n* Serum ferritin ≥ 100\n* May continue on current MPN treatment, including aspirin, hydroxyurea, interferon-alpha, ruxolitinib, fedratinib, or anagrelide.\n* Peripheral blast count \\\u003C10% during Screening.\n* Free of other known active or metastatic malignancies other than localized skin cancer.\n* Amenable to blood draws and symptom assessments.\n* Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3\n* Currently pregnant or planning on being pregnant within the study period.\n* Currently taking Momelotinib or Pacritinib (these agents are purported to reduce hepcidin).\n* Currently taking any of the contraindicated medications to Nelfinavir listed in section 13.2\n* Currently breastfeeding.\n* Known uncontrolled active viral or bacterial infection.\n* Known HIV+\n* Significant impairment of major organ or hematopoietic function defined as\n\n  1. Serum creatinine clearance less than 30 ml\u002Fmin (eGFR).\n  2. Bilirubin more than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.\n  3. Platelets \\\u003C 50 × 10\\^9\u002FL without transfusions\n  4. ANC \\\u003C 0.75 × 10\\^9\u002FL without growth factors\n* Known history of allergic reaction to nelfinavir.",{"count":631,"type":21},10,[52,24],"This is a phase I\u002FII protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.",[28,55],[28,56,636],"Nelfinavir","2026-04-28",{"date":639,"type":33},"2026-05-04",{"date":641,"type":33},"2025-09-16",{"date":70,"type":21},{"name":644,"class":40},"University of California, Irvine",{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":673},"100576115","feasibility-trial-of-extracorporeal-iron-purification-in-patients-with-myelodysplastic-syndrome-or-myelofibrosis-100576115","NCT06781099","Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis","Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.","MEXIRON","Inclusion Criteria:\n\n* Patient followed for myelodysplastic syndrome or myelofibrosis.\n* Patient with platelet count ≥50 giga\u002FL at inclusion.\n* Patients with severe anemia and hemoglobin \\\u003C70 g\u002FL at baseline.\n* Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.\n* Ferritinemia \\>1000 µg\u002FL or hepatic iron concentration ≥7 mg\u002Fg or cardiac T2\\* \\\u003C20 ms at inclusion.\n* Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.\n\nExclusion Criteria:\n\n* Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf \\> 45%).\n* Patients with a contraindication to the use of MEX-CD1: weight \\\u003C 30 kg, iron deficiency.\n* Patients with a known allergy or contraindication to heparin or citrate.\n* Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.\n* Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.\n* Patients with indications for allogeneic bone marrow transplantation.\n* Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1.\n* Patients with a peripheral vascular access that is difficult to access or that needs to be preserved.\n* Patients participating in other interventional research that could interfere with the results of the study.\n* Patients under legal protection or unable to express their consent.\n* Patients under psychiatric care.\n* Patient deprived of liberty by judicial or administrative decision.\n* Pregnant or breast-feeding women.",{"count":654,"type":21},13,[656],"NA","In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach.\n\nMEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis.\n\nMEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed.\n\nEach enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week.\n\nFollowing the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.",[223,28],[660,661,662,663],"Myelodysplastic syndrome","myelofibrosis","iron chelation therapy","haemodialysis","2026-04-22",{"date":666,"type":33},"2026-04-23",{"date":668,"type":33},"2026-01-06",{"date":670,"type":21},"2027-05-06",{"name":672,"class":40},"Hospices Civils de Lyon",2,{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":209,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":681,"targetDuration":4,"studyType":22,"phases":682,"briefSummary":683,"conditions":684,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":691,"locationsCount":673},"100629911","phase-1-to-evaluate-the-pharmacokinetics-and-safety-of-tq05105-tablet-in-hepatic-impairment-subjects-100629911","NCT07480824","To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects","Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQ05105 in Participants With Mild Hepatic Impairment (Child-Pugh A), Moderate Hepatic Impairment (Child-Pugh B), and Healthy Subjects","Inclusion Criteria:\n\n* Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions.\n* Patients (including partners) have no pregnancy plans or sperm\u002Fegg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception.\n* Aged 18-75 years (inclusive), regardless of gender.\n* Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)\u002Fheight² (m²), with BMI ranging 18.0-32.0 kg\u002Fm² (inclusive).\n* Patients can communicate effectively with investigators and comply with the trial protocol.\n\nAdditional Criteria for Participants with Normal Liver Function:\n\n* Negative serum HBsAg and Hepatitis C Virus (HCV) antibody test results.\n* Weight within ±10 kg of the average weight of groups A\u002FB; age within ±10 years of the average age of groups A\u002FB; gender distribution similar to groups A\u002FB (±1 participant per gender).\n\nAdditional Criteria for Participants with Impaired Liver Function:\n\n* Chronic liver injury caused by primary liver diseases (e.g., hepatitis B\u002FC, non-alcoholic fatty liver disease, alcoholic liver disease) or clinically diagnosed cirrhosis, classified as Child-Pugh Grade A or B.\n* Stable condition within 2 weeks prior to dosing as judged by the investigator.\n* No medication within 4 weeks before screening, or stable treatment regimen for underlying diseases (including liver-protective therapy).\n\nExclusion Criteria:\n\n* History or current diagnosis of severe\u002Fchronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function).\n* Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes.\n* Use of strong\u002Fmoderate CYP3A4, CYP2C9, or CYP2C19 inducers\u002Finhibitors within 4 weeks before screening.\n* Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash\u002Feczema\u002Fasthma).\n* Average daily smoking \\>5 cigarettes within 3 months before screening.\n* Drug abuse history or positive urine drug screen within 3 months.\n* For alcoholic liver disease participants: history of excessive drinking (\\>2 alcohol units\u002Fday) within 1 year; for others: such history within 3 months.\n* Blood donation\u002Floss ≥200 mL or plasmapheresis within 4 weeks before screening.\n* Consumption of alcohol (or positive breath test), grapefruit juice, coffee, tea, cola, or chocolate within 48 hours before dosing.\n* Creatinine clearance (CLcr) \\\u003C60 mL\u002Fmin.\n* Pregnant\u002Flactating women, positive pregnancy test, or unprotected sex within 2 weeks before screening.\n* Positive HIV antibody or Treponema pallidum-specific antibody.\n* Other factors deemed unsuitable by the investigator.\n\nAdditional Exclusions for Normal Liver Function Participants:\n\n* Use of prescription\u002Fnon-prescription drugs, herbal medicines, or supplements (e.g., vitamins) within 2 weeks before screening.\n* The results of physical examination during the screening period, vital signs, clinical laboratory tests (blood cell analysis (five categories), blood biochemistry, coagulation function, urine routine examination with sediment), electrocardiogram, frontal and lateral chest X-rays, abdominal ultrasound (liver, gallbladder, pancreas, spleen), and urinary system ultrasound, etc., which showed abnormal results and were determined by the research doctor to have clinical significance.\n* Patients in other drug trials within 3 months or 5 half-lives (whichever longer) before screening.\n\nAdditional Exclusions for Impaired Liver Function Participants:\n\n* Had a history of liver transplantation;\n* Patients with hepatic coma within 30 days before screening;\n* Patients who had used drugs that might cause acute hepatotoxicity (such as halothane and methotrexate) within 3 months before screening;\n* Patients with acute liver disease caused by drug or viral infection within 2 months before screening;\n* With biliary cirrhosis, liver\u002Fbile duct obstruction, cholestatic liver disease and other diseases affecting biliary excretion;\n* Patients with liver failure or liver cancer, or patients with a history of esophagogastric variceal bleeding, hepatic encephalopathy, severe portal hypertension, or a portasystemic shunt within 1 year before screening who were judged by the investigator to be ineligible for the trial;\n* Patients with abnormal physical examination, vital signs, clinical laboratory tests (blood cell analysis (five classification), blood biochemistry, coagulation function, urine routine and sediment), AFP, electrocardiogram, chest X-ray, echocardiography, abdominal ultrasound (liver, gallbladder, pancreas and spleen), urinary ultrasound, and routine electroencephalogram (EEG) during the screening period and judged by the research doctors as not suitable for the study;\n* Patients with massive ascites on ultrasound during the screening period who were assessed by the investigators as not suitable for the trial;\n* Who participated in and used any investigational drug within 1 month before screening.",{"count":333,"type":21},[52],"This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.",[28],"2026-04-03",{"date":687,"type":33},"2026-04-06",{"date":689,"type":33},"2026-04-01",{"date":199,"type":21},{"name":332,"class":73}]