[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelofibrosis-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelofibrosis-anemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,83,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100463861","phase-1-study-of-disc-0974-rally-mf-in-participants-with-myelofibrosis-or-myelodysplastic-syndrome-and-anemia-100463861",false,"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","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32,33],"Myelofibrosis; Anemia","Anemia","Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Primary Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Myelodysplastic Syndromes",[35,36],"Myeloproliferative Neoplasm","Myeloproliferative Disorders","RECRUITING","2026-08-10",{"date":40,"type":41},"2026-08-12","ACTUAL",{"date":43,"type":41},"2022-06-06",{"date":45,"type":20},"2027-06",{"name":47,"class":48},"Disc Medicine, Inc","INDUSTRY",30,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"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":59,"type":20},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.",[29,30,63,64,65,66,67,68,27,69,70,71],"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",[73],"Myelofibrosis. JAK inhibitor therapy. De-novo diagnosis. Prior JAK inhibitor therapy. Novel JAK inhibitor. JAK2. FLT3. CDK6.","NOT_YET_RECRUITING","2026-08-05",{"date":38,"type":41},{"date":78,"type":20},"2026-11",{"date":80,"type":20},"2028-11",{"name":82,"class":48},"Chengdu Zenitar Biomedical Technology Co., Ltd",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"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":92,"type":20},200,"OBSERVATIONAL","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.",[31,96,97,32,28,27,29],"Secondary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","2026-06-03",{"date":100,"type":41},"2026-06-05",{"date":102,"type":41},"2026-02-19",{"date":104,"type":20},"2031-09",{"name":106,"class":48},"iOMEDICO AG",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":127,"locationsCount":107},"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":115,"type":20},10,[23,24],"This is a phase I\u002FII protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.",[29,27],[29,28,120],"Nelfinavir","2026-04-28",{"date":123,"type":41},"2026-05-04",{"date":125,"type":41},"2025-09-16",{"date":45,"type":20},{"name":128,"class":129},"University of California, Irvine","OTHER"]