[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,79,0,25,[9,42,73,100,121,171,197,215,236,264,285,319,341,364,384,431,472,493,517,544,570,592,616,634,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"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},"100652853","phase-1-study-of-monzosertib-in-patients-with-rr-aml-or-high-risk-myelodysplastic-syndrome-100652853",false,"NCT07780565","Study of Monzosertib In Patients With R\u002FR AML Or High-Risk Myelodysplastic Syndrome","Phase 1b Study of Monzosertib In Patients With Relapsed Or Refractory Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Patients need to be adults ≥18 years with R\u002FR AML, 'MDS\u002FAML', MDS, or CMML, per the ICC 2022 or the WHO 2022 with ≥5% blasts at screening. 6,7\n2. Relapsed or refractory disease is defined as: patient having received and have progressed or relapsed or intolerant to standard regimens, e.g., as listed in NCCN guidelines, or declined treatment with such therapies.\n\n   a. This may include at least one cycle of intensive chemotherapy for AML, or for AML\u002FMDS\u002FCMML at least 2 cycles of BCL2 inhibitor based lower intensity regimen or 4 cycles of HMA-based regimens without BCL2 inhibitor, or clear progression during such treatment.\n3. \"Treated secondary AML\" i.e., patients with antecedent hematological disorder, e.g., MDS, CMML, MPD\u002FMPN, who progress to AML despite receiving treatment adequate for AML (per NCCN) for the antecedent hematological disorder, will be eligible due to recognized poor outcomes similar to R\u002FR AML.\n\n   8,9\n4. Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1\u002F2, menin inhibitors may be enrolled after they have exhausted or ineligible for appropriate lines of FDA approved treatment options.\n5. ECOG PS 0 to 2\n6. Adequate hepatic function (total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and\u002For ALT ≤ 3 x ULN will be considered eligible).\n7. Adequate renal function with creatinine clearance ≥ 30 mL\u002Fmin calculated by the CockcroftGault formula or MDRD equation.\n8. Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic (\"replacement\") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.\n9. The effects of these agents on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men 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 at least 90 days after last treatment.\n\n   a. This includes all female patients between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   b. Approved methods of birth control are as follows: 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.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has a white blood cell count \\> 15 x 10⁹\u002FL. Hydroxyurea, and\u002For cytarabine use as supportive care is permitted to meet this criterion.10\n2. Prior use of any cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational therapies within 2 weeks or 5 half-lives (whichever is shorter), prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.\n3. Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs\u002Fsymptoms despite appropriate treatment.\n4. Decompensated congestive heart failure, clinically significant, uncontrolled arrhythmia prolonged QT interval corrected for heart rate (QTcF) to greater than 450 msec, or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and\u002For cardiologist. Acute respiratory failure, unstable or decompensated pulmonary disease\n5. Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.\n6. Active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection. Patients with history of hepatitis with undetectable viral load will be eligible.\n7. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator.\n8. Any previous malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and\u002For surgery and\u002For radiotherapy at least 1 month prior to enrollment. Patients having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination or imaging or cytology\u002Fpathology, e.g., non-melanoma skin cancers, or any carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.\n9. Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.\n10. Patients under legal protection measure (guardianship, trusteeship or safeguard of justice) and\u002For uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, inability, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.\n11. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.\n12. Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed\u002Frefractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.",[27,28],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome","NOT_YET_RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":21},"2027-01-01",{"date":37,"type":21},"2031-08-30",{"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":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100637009","phase-1-study-of-quail-100-in-pediatric-and-young-adult-participants-with-high-risk-hematologic-malignancies-who-have-received-a-hematopoietic-stem-cell-transplantation-100637009","NCT07573111","Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation","An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell\u002FCD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Weight \\>\u002F= 10 kg\n* Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment\n* Lanksy\u002FKarnofsky score \\> 60\n* Participants of childbearing potential must agree to use contraception to prevent pregnancy\n\nExclusion Criteria:\n\n* Active Grade II acute graft versus host disease (aGVHD) requiring \\> 0.5 mg\u002Fkg methylprednisolone or any diagnosis of Grade III\u002FIV aGVHD\n* Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation\n* Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin\n* Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention\n* Planned anti-leukemic therapy within 21 days of planned dosing\n* Use of tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening\n* Any prior investigational Listeria product including QUAIL-100\n* Live, attenuated vaccine within 4 weeks of first dose","18 Months","39 Years",{"count":52,"type":21},12,[24],"Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant",[56,28],"Acute Leukemia",[58,59,60,27,61,62,63],"Leukemia","Myelodysplastic Syndrome (MDS)","Acute Lymphocytic Leukemia (ALL)","transplant","hematopoietic stem cell transplant","LGNA-100","RECRUITING",{"date":32,"type":33},{"date":67,"type":21},"2026-08",{"date":69,"type":21},"2029-03",{"name":71,"class":72},"Laguna Biotherapeutics, Inc.","INDUSTRY",{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100482619","phase-2-myelomatch-a-screening-study-to-assign-people-with-myeloid-cancer-to-a-treatment-study-or-standard-of-care-treatment-within-myelomatch-myelomatch-screening-trial-100482619","NCT05564390","MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)","Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials","Inclusion Criteria:\n\n* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.\n* Participants must be \\>= 18 years of age.\n* Participants must not have received prior anti-cancer therapy for AML or MDS.\n\n  * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.\n  * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g\u002Fm\\^2 of cytarabine, which is allowed for urgent cytoreduction.\n* Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.\n\n  * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.\n* Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy\n\n  * Note: active hormonal therapy is allowed\n* Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.\n* Participants must agree to have translational medicine specimens submitted.\n* Participants must be offered the opportunity to participate in specimen banking.\n\n  * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.",{"count":81,"type":21},2000,[83],"PHASE2","This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).",[86,87,88,89,28],"Acute Myeloid Leukemia","Acute Myeloid Leukemia Arising From Previous Myelodysplastic\u002FMyeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemia, Myelodysplasia-Related",{"date":91,"type":33},"2026-08-20",{"date":93,"type":33},"2024-06-18",{"date":95,"type":21},"2029-05-15",{"name":97,"class":98},"National Cancer Institute (NCI)","NIH",348,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":41},"100336506","phase-1-quizartinib-decitabine-and-venetoclax-in-treating-participants-with-untreated-or-relapsed-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100336506","NCT03661307","Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Diagnosis of 1) AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts) excluding acute promyelocytic leukemia (APL) or 2) MDS with \\> 10% blasts (defined by the International Prognostic Scoring System \\[IPSS\\] classification).\n* For frontline Cohort: Patients aged \\>= 60 years old who are not candidates for intensive induction therapy and agree to receive the proposed combination therapy will be enrolled.\n* Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:\n\n  * 75 years of age OR\n  * \\\u003C 75 years of age with at least 1 of the following:\n\n    * Poor performance status (Eastern Cooperative Oncology Group \\[ECOG\\]) score of 2-3.\n    * Clinically significant heart or lung comorbidities, as reflected by at least 1 of:\n\n      * Left ventricular ejection fraction (LVEF) =\\\u003C 50%.\n      * Lung diffusing capacity for carbon monoxide (DLCO) =\\\u003C 65% of expected.\n      * Forced expiratory volume in 1 second (FEV1) =\\\u003C 65% of expected.\n      * Chronic stable angina or congestive heart failure controlled with medication.\n  * Liver transaminases \\> 3 x upper limit of normal (ULN).\n  * Other contraindication(s) to anthracycline therapy (must be documented).\n  * Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the principal investigator (PI).\n* Patients with newly diagnosed AML with poor risk complex karyotype and\u002For TP53 deletions\u002Fmutations equal or younger than 60 year old\n* For relapsed cohort: Patients aged \\>= 18 years old. (Patients who are candidates for relapse cohort will be enrolled into the study regardless of their fitness for intensive chemotherapy). (a) Patients with relapsed\u002Frefractory AML are eligible if they are not eligible for potentially curative therapy such as effective salvage therapy or hematopoietic stem cell transplantation or who refuse these options at the time of enrollment.\n* Detection of FLT3-ITD mutation or FLT3-ITD\u002FTKD co-mutations in bone marrow and\u002For peripheral blood samples within 30 days prior to study enrollment.\n* For frontline cohort: Patients must be chemonaive, i.e. not have received any chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis) for AML or MDS. They may have received transfusions, hematopoietic growth factors or vitamins for an antecedent hematological disorder (AHD) or for AML. Temporary prior measures such as apheresis, all-trans-retinoic acid (ATRA), steroids or hydrea while diagnostic work-up is being performed are allowed and not counted as a prior salvage. Supportive care therapy for MDS (growth factors, transfusions) will not be considered as prior therapy for MDS\u002FAML and these patients will be enrolled to the frontline cohort of the study if they are otherwise eligible.\n* For relapsed cohort: Patients who have received at least one prior therapy for AML or for MDS with \\> 10% blasts will be eligible. Patients may have received up to 4 prior salvages for AML and\u002For MDS (defined by the IPSS classification). Prior therapy for AML or MDS will be counted as a prior salvage. Patients who receive MDS directed therapies considered not purely supportive such as HMAs, lenalidomide, investigational therapies, will be enrolled to the salvage cohort if they are otherwise eligible.\n* In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for cytotoxic\u002Fnoncytotoxic agents. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document\n* The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the PI a (2) Use of one dose of cytarabine (up to 2 g\u002Fm\\^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. These medications will be recorded in the case-report form.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2.\n* Serum biochemical values with the following limits unless considered due to leukemia, hemolysis or congenital disorder (creatinine \\\u003C 1.8 mg\u002Fdl, total bilirubin \\\u003C 1.8 mg\u002FdL, \\[serum glutamate pyruvate transaminase (SGPT)\\] \\\u003C 2.5 x upper limit of normal).\n* White blood cell count \\\u003C 25 x 10\\^9\u002FL\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be within institutional normal limits.\n* Ability to take oral medication.\n* Ability to understand and provide signed informed consent.\n* Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) \\>= 50%.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.\n* WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy until at least 3 months after the last dose of investigational drug. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as men with azoospermia do not require contraception.\n* Negative urine or serum pregnancy test.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an Investigational New Drug (IND).\n\nExclusion Criteria:\n\n* Patients with known allergy or hypersensitivity to quizartinib, mannitol, decitabine or any of their components.\n* Prior quizartinib use.\n* Patients with known uncontrolled CNS leukemia.\n* Only for frontline cohort: patients who are fit for intensive chemotherapy.\n* Patients with electrolyte abnormalities at study entry defined as follows: Serum potassium \\\u003C 3.5 mEq\u002FL despite supplementation, or \\> 5.5 mEq\u002FL Serum magnesium above or below the institutional normal limit despite adequate management. Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management.\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib.\n* Patients with any other known concurrent severe and\u002For uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.\n* Patients with a known human immunodeficiency virus (HIV) infection.\n* Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., hepatitis B surface antigen \\[HBs Ag\\]-, and anti-HBs+\\] may participate.\n* Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n* Patients who have had any major surgical procedure within 14 days of day 1.\n* Impaired cardiac function including any of the following: Screening ECG with a Fridericia's correction formula (QTcF) \\> 450 msec. The QTcF interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate EKGs can show false corrected QT (QTc) prolongation; therefore, the Cardiology collaborator for this study will manually review to provide an accurate reading of the QTc. Patients with congenital long QT syndrome. History or presence of sustained ventricular tachycardia requiring medical intervention. Any history of clinically significant ventricular fibrillation or torsades de pointes. Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker). Sustained heart rate of \\\u003C 50\u002Fminute on pre-entry ECG. Right bundle branch block + left anterior hemiblock (bifascicular block). Complete left bundle branch block. Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug. Congestive heart failure (CHF) New York (NY) Heart Association class III or IV. Atrial fibrillation documented within 2 weeks prior to first dose of study drug. Patients who are actively taking a strong CYP3A4 inducing medication.\n* Patients who require treatment with concomitant drugs that prolong QT\u002FQTc interval or strong CYP3A4 inhibitors with the exception of antibiotics, antifungals, and antivirals that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with a potentially QTc-prolonging medication (such as anti-emetic except for prochlorperazine) is vital to an individual subject's care while on study.\n* Known family history of congenital long QT syndrome.\n* Patients who are on strong CYP3A4 inhibitor will be excluded.",{"count":108,"type":21},73,[24,83],"This phase I\u002FII trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.",[86,28,112,113,114],"Recurrent Acute Myeloid Leukemia","Recurrent Myelodysplastic Syndrome","Refractory Acute Myeloid Leukemia",{"date":91,"type":33},{"date":117,"type":33},"2018-10-31",{"date":119,"type":21},"2028-01-01",{"name":39,"class":40},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":141,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":41},"100652810","chip-in-health-and-disease-100652810","NCT07780552","CHIP in Health and Disease","DECONVOLUTION OF CLONAL HEMATOPOIESIS ASSOCIATED INFLAMMATION IN HEALTH AND DISEASE","CHIP2","Inclusion Criteria: Participants must be ≥18 years of age and meet at least one of the following criteria:\n\n* Written informed consent has been obtained for participation in the study \"Deconvolution of Clonal Hematopoiesis-Associated Inflammation in Health and Disease\"; OR\n* Participant is enrolled in the Inn.Health study and has provided written informed consent; OR\n* Participant is enrolled in the study \"Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction\" and has provided written informed consent.\n\nGroup A: Control Group (n=20)\n\n* Age ≥60 years\n* No detectable somatic variant identified by peripheral blood next-generation sequencing (NGS)\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment Group B: Low-Risk Clonal Hematopoiesis Risk Score (CHRS) Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with variant allele frequency (VAF) ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment\n* Low-risk CHRS (\\\u003C9.5 points) Group C: Intermediate-\u002FHigh-Risk CHRS Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment\n* Intermediate- or high-risk CHRS (\\>9.5 points) Group D: Clonal Cytopenia of Undetermined Significance (CCUS) Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* Untreated, unexplained cytopenia present for ≥4 months\n* Hemoglobin \\\u003C13 g\u002FdL (men) or \\\u003C12 g\u002FdL (women), and\u002For absolute neutrophil count \\\u003C1.8 × 10⁹\u002FL, and\u002For platelet count \\\u003C150 × 10⁹\u002FL\n* No diagnostic criteria for a defined myeloid neoplasm based on bone marrow examination Group E: Cardiovascular Disease Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) within the previous 4 months\n* No history of coronary artery bypass grafting (CABG)\n* No history of stroke\n* No cytopenia at study enrollment\n* No diagnosis of a WHO-defined neoplasm Group F: Low-Risk Myelodysplastic Syndrome (MDS) Group (n=20)\n* Age ≥60 years\n* Untreated, newly diagnosed (\\\u003C3 months from diagnosis) low-risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System (IPSS-R score \\>1.5 to 3.0)\n* No history of stroke or myocardial infarction\n\nExclusion Criteria:\n\n* Treatment with immunosuppressive medication within the previous 4 weeks, including but not limited to systemic corticosteroids, methotrexate, other disease-modifying antirheumatic drugs (DMARDs), colchicine, TNF-α inhibitors, mTOR inhibitors, calcineurin inhibitors, or immunomodulatory antibodies\n* History of rheumatologic, autoinflammatory, or autoimmune disease",true,{"count":131,"type":21},120,"OBSERVATIONAL","Clonal hematopoiesis (CH), including clonal hematopoiesis of indeterminate potential (CHIP), is an age-associated condition characterized by the expansion of hematopoietic stem and progenitor cell clones carrying acquired somatic mutations. Although CH is associated with an increased risk of hematologic malignancies, its greater public health impact derives from its strong association with cardiovascular diseases, including coronary artery disease and stroke. Emerging evidence suggests that CH-associated mutations promote chronic inflammatory signaling in myeloid immune cells, thereby contributing to atherosclerosis and adverse cardiovascular remodeling.\n\nThis observational translational study aims to characterize the biological spectrum of clonal hematopoiesis across different stages of disease risk and manifestation. Using state-of-the-art single-cell and multi-omics approaches, the study will compare inflammatory pathways, immune cell states, and mutation-associated molecular programs among healthy individuals without CH, individuals with high-risk CH, and patients with CH-associated hematologic or cardiovascular disease. The ultimate goal is to identify shared and disease-specific mechanisms linking clonal hematopoiesis to adverse clinical outcomes and to generate insights for future preventive, anti-clonal, and anti-inflammatory therapeutic strategies.",[135,136,137,28,138,139,140],"Clonal Hematopoiesis","Clonal Hematopoiesis of Indeterminate Potential","Clonal Cytopenia of Undetermined Significance (CCUS)","Cardiovascular Disease","Myocardial Infarction (MI)","ST-elevation Myocardial Infarction (STEMI)",[135,142,143,144,145,146,147,148,138,149,150,151,137,152,153,154,155,156,157,158,159,160,161,162],"Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Somatic Mutations","DNMT3A","TET2","ASXL1","Inflammation","Myeloid Cells","Atherosclerosis","Myocardial Infarction","STEMI","Myelodysplastic Syndromes (MDS)","Single-Cell RNA Sequencing","Multi-Omics","Immune Profiling","NLRP3 Inflammasome","cGAS-STING Pathway","Precision Medicine","Cardiovascular Risk","Healthy Aging","Chronic Inflammation","Biomarkers","2026-08-18",{"date":32,"type":33},{"date":166,"type":21},"2026-10",{"date":168,"type":21},"2027-03",{"name":170,"class":40},"VASCage GmbH",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":41},"100639858","phase-2-total-marrow-and-lymphoid-irradiation-in-combination-with-fludarabine-and-melphalan-as-conditioning-for-allogeneic-peripheral-blood-stem-cell-hematopoietic-cell-transplant-in-older-patients-with-refractory-and-relapsed-acute-myeloid-leukemia-and-high-risk-myelodysplastic-syndrome-100639858","NCT07582172","Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome","Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 50 years (no upper age limit)\n\n  * Note: Patients ≥ 18 years and \\\u003C 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease\n* Karnofsky or Lansky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:\n\n  * Acute myeloid leukemia (AML):\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups\n    * Patients with active disease:\n\n      * Morphologically\n      * Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)\n  * Myelodysplastic syndrome\u002Fchronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast\n* Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8\u002F8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells\n* Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\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* Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy\n\n  * Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen\n* More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission\n* Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* 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* 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)",{"count":179,"type":21},35,[83],"This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and\u002For effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.",[183,184,28,112,185,113,186,114,187,188,189],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Secondary Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic Syndrome","Refractory Secondary Acute Myeloid Leukemia",{"date":91,"type":33},{"date":192,"type":21},"2027-04-05",{"date":194,"type":21},"2029-04-05",{"name":196,"class":40},"City of Hope Medical Center",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100563474","phase-1-a-phase-ib-study-of-rezatapopt-in-combination-with-azacitidine-in-patients-with-tp53y220c-mutant-myeloid-malignancies-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100563474","NCT06616636","A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)","Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Patient has relapsed or primary refractory AML or MDS\n4. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy.\n5. Patients with MDS must be classified as MDS-IB1 or IB2 as per WHO 2022 criteria32\n6. TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency \\>2%.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n8. Patient has adequate organ function defined as:\n\n   * Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n   * Serum total bilirubin ≤ 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert\\'s syndrome.\n   * Serum creatinine \\< 2 x ULN or creatinine clearance \\> 40 mL\u002Fmin based on validated glomerular filtration rate (GFR) estimation (Cockcroft-Gault, CKD-epi, or MDRD equations).\n9. Females of childbearing potential may participate provided they have a negative serum or urine pregnancy test at screening and a negative serum OR urine pregnancy test within 72 hours of starting on treatment. They also must agree to either abstain from sexual intercourse or use two forms of a highly effective method of contraception while on study and up to 3 months after the last dose of the study drug.\n10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 14 days prior to study entry and for the duration of study participation. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    • Approved methods of birth control are as follows: 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\n    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 3 months after completion of investigational agent administration.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has received prior chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 14 days or 5 half-lives (if half-life is known), whichever is shorter, before receiving their first dose of study drug.\n2. Patient has received radiotherapy within 14 days.\n3. Patients with acute promyelocytic leukemia\n4. Subject has immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation.\n5. Patients with active, uncontrolled leukemia involvement of the CNS\n6. Subject has known active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n7. Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n8. Subject has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n9. Patient has any unresolved toxicities from prior anti-cancer therapy greater than Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior chemotherapy induced neuropathy.\n10. Patient has had major surgery within 2 weeks prior to the planned start of study treatment.\n11. Female subject who is pregnant or lactating.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, rezetapopt or other agents used in study.",{"count":204,"type":21},24,[24],"A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.",[28,86],{"date":91,"type":33},{"date":210,"type":33},"2025-01-30",{"date":212,"type":21},"2029-08-27",{"name":39,"class":40},2,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100321927","phase-1-ivosidenib-and-venetoclax-with-or-without-azacitidine-in-treating-patients-with-idh1-mutated-hematologic-malignancies-100321927","NCT03471260","Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies","Phase Ib\u002FII Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +\u002F- Azacitidine in IDH1-Mutated Hematologic Malignancies","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. ECOG performance status of \\\u003C 2.\n3. IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the PI.\n4. Relapsed\u002Frefractory AML, or treatment-naïve patients with AML who are not eligible for standard induction chemotherapy. Patients with high-risk MDS, MDS\u002FMPN or MPN (defined as \\> 10% bone marrow blasts, or intermediate or high risk by IPSS, R-IPSS or D-IPSS) that have failed standard therapy may also be eligible after discussion with the PI.\n5. Adequate hepatic function (direct bilirubin \\\u003C 2 x ULN, ALT and\u002For AST \\\u003C 3x ULN) unless deemed to be related to underlying leukemia.\n6. Adequate renal function including creatinine clearance \\> 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n7. Willing and able to provide informed consent\n8. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n9. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Patients with known allergy or hypersensitivity to ivosidenib or venetoclax.\n2. Patients who have previously received either ivosidenib or venetoclax.\n3. Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n4. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea and\u002For one dose of cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.\n5. Patients receiving concomitant strong CYP3A inducers (avasimibe, carbamazepine, phenytoin, rifampin, rifabutin, St. John's wort) within 3 days of start of study therapy.\n6. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n7. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Patients with a concurrent active malignancy under treatment.\n9. QTc interval using Fridericia's formula (QTcF) \\> 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI.\n10. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n11. Subject has a white blood cell count \\> 25 x 10⁹\u002FL. (Note: Hydroxyurea is permitted to meet this criterion.)\n12. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).",{"count":223,"type":21},96,[24,83],"This phase Ib\u002FII trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.",[86,227,28,228,112,114],"Hematopoietic and Lymphoid System Neoplasm","Myeloproliferative Neoplasm",{"date":91,"type":33},{"date":231,"type":33},"2018-03-19",{"date":233,"type":21},"2027-09-30",{"name":39,"class":40},4,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":246,"conditions":247,"keywords":251,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":4,"leadSponsor":262,"locationsCount":263},"100125401","collection-of-tissue-samples-for-cancer-research-100125401","NCT00900198","Collection of Tissue Samples for Cancer Research","Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)","* INCLUSION CRITERIA - ADULT:\n* Patients 18 years of age and older who are being evaluated and\u002For treated for cancer at the NIH Clinical Center or at participating sites:\n\n  * Who have a newly diagnosed malignancy for which they have not yet received treatment, or\n  * Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\n\n    * radiographic evidence of tumor growth and\u002For new metastases, or\n    * CBC w\u002Fdifferential and\u002For flow cytometry, or\n    * documented evidence by the treating physician of signs\u002Fsymptoms of clinical disease progression, or\n  * Who are currently undergoing treatment and for whom disease response has not yet been assessed,\n\n    ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.\n  * Patients with ongoing partial response (PR) or stable disease (SD) are eligible.\n\n    * For solid tumor diagnoses, confirmation of viable malignancy and\u002For \\\u003C90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.\n    * For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final flow cytometry report.\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.\n\nAt the NIH Clinical Center ONLY:\n\n* At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and\u002For treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.\n* Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and\u002For treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and\u002For MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.\n\n  * Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.\n\nEXCLUSION CRITERIA:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as but not limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).\n* Patients with invasive fungal infections.\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.\n  * Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible.\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR).\n\nINCLUSION CRITERIA - PEDIATRIC:\n\n* Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.\n* Ability and willingness to assent to participation, utilizing an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission.\n\nAt the NIH Clinical Center ONLY\n\n-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.\n\nEXCLUSION CRITERIA - PEDIATRIC:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics should be completed at least 1 week (7 days) prior to collection\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.\n* Blood only collections from patients with partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.","2 Months",{"count":245,"type":21},5000,"Background:\n\n-Patients who are being evaluated and\u002For treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.\n\nObjectives:\n\n* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.\n* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.\n\nEligibility:\n\n-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and\u002For treated for cancer at the NIH Clinical Center participating sites.\n\nDesign:\n\n* This is a multicenter tissue procurement protocol with NCI as the coordinating center.\n* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.\n* For pediatric patients: tumor biopsy\u002Fresection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.\n* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents\u002Fguardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.\n* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.\n* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.",[248,249,250,28],"Neoplasms","Lymphomas","Multiple Myeloma",[252,253,254,255,256,257],"Tissue Collection","Biospecimen","Assay Development","Tissue Acquisition","Tissue Biopsies","Natural History","2026-08-15",{"date":163,"type":33},{"date":261,"type":33},"2006-07-06",{"name":97,"class":98},17,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100560461","testing-the-addition-of-an-idh2-inhibitor-enasidenib-to-usual-treatment-cedazuridine-decitabine-for-higher-risk-myelodysplastic-syndrome-mds-with-idh2-mutation-a-myelomatch-treatment-trial-100560461","NCT06577441","Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)","A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study","Inclusion Criteria:\n\n* GENERAL MYLEOMATCH REGISTRATION CRITERIA:\n\n  * Patients must be registered to the Master Screening and Reassessment Protocol (MYELOMATCH) and assigned to this protocol by the MATCHBox Treatment Verification Team.\n  * Participants must not have received prior anti-cancer therapy for AML or MDS.\n\n    * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.\n    * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility.\n  * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g\u002Fm\\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine).\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \\[g-CSF\\], thrombopoietin \\[TPO\\] agonist) or luspatercept is allowed.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with lenalidomide with a maximum limit of 1 month of exposure is allowed.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x upper limit of normal (ULN).\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL\u002Fmin\n\n  * To be calculated using Cockroft Gault formula.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN).\n\n  * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)\u002FALT (SGPT) ≤ 3.0 x upper limit of normal (ULN)\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL\u002Fmin\n\n  * To be calculated using Cockroft Gault formula.\n* RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.",{"count":272,"type":21},54,[83],"This phase II MyeloMATCH treatment trial compares the usual treatment of cedazuridine-decitabine (ASTX727) to the combination treatment of ASTX727 and enasidenib in treating patients with higher-risk, IDH2-mutated myelodysplastic syndrome (MDS). ASTX727 is a combination of two drugs, decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Enasidenib is an enzyme inhibitor that may stop the growth of cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with enasidenib may be effective in treating patients with higher-risk IDH2-mutated MDS.",[28],"2026-08-14",{"date":278,"type":33},"2026-08-17",{"date":280,"type":33},"2025-06-12",{"date":282,"type":21},"2027-03-01",{"name":97,"class":98},143,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":293,"targetDuration":295,"studyType":132,"phases":4,"briefSummary":296,"conditions":297,"keywords":304,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":41},"100651557","low-dose-liposomal-amphotericin-b-for-antifungal-prophylaxis-in-prolonged-neutropenia-patients-100651557","NCT07763054","Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients","Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive), both sexes.\n* Meets NCCN 2025 V1 guideline criteria for high-risk invasive fungal disease, including allogeneic hematopoietic stem cell transplantation, autologous hematopoietic cell transplantation with mucosal damage, acute leukemia, grade 3\u002F4 graft-versus-host disease, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic lymphocytic leukemia, treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \\>7 days and accompanied by agranulocytosis.\n\nNote: Agranulocytosis is defined as absolute neutrophil count ≤0.5×10\\^9\u002FL, or absolute neutrophil count ≤1×10\\^9\u002FL with expected decline to ≤0.5×10\\^9\u002FL within 48 hours.\n\n* Assessed by the study physician as having high-risk for invasive fungal infection, intolerant or unable to use other antifungal agents due to toxicity or other reasons, and the treating physician has independently decided in routine clinical practice to initiate liposomal amphotericin B for antifungal prophylaxis for 3-5 days, with the selected dosage regimen of 50 mg\u002Fday, intravenous, once daily.\n* Patient or legally authorized representative has voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Allergy to any component of liposomal amphotericin B, or development of serious adverse events during the initial 3-5 days of prophylactic use.\n* Prior history of proven or probable invasive fungal disease (IFD).\n* Presence of pneumonia, unexplained fever, or clinical\u002Fimaging evidence suggestive of or diagnosed as fungal infection during screening.\n* Clinically significant hypokalemia (defined as serum potassium \\\u003C3.2 mmol\u002FL, or below the lower limit of normal while receiving digitalis therapy) that cannot be corrected before starting trial treatment.\n* Hepatic dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5× upper limit of normal (ULN), or total bilirubin ≥3× ULN.\n* Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis.\n* New York Heart Association (NYHA) Class III\u002FIV heart failure.\n* Positive for human immunodeficiency virus (HIV) antibody or Treponema pallidum hemagglutination assay (TPHA).\n* Expected survival \\\u003C3 months.\n* Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception and planning pregnancy.\n* Any other condition that the investigator considers inappropriate for participation in the clinical trial.","75 Years",{"count":294,"type":21},30,"7 Days","This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg\u002Fday, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10\\^9\u002FL, expected to last \\>7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg\u002Fday due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever \\>4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.",[86,298,28,299,250,300,301,302,303],"Acute Lymphoblastic Leukemia","Lymphoma","Chronic Lymphocytic Leukemia","Neutropenia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Invasive Fungal Infections",[305,306,307,308,309],"Liposomal Amphotericin B","Antifungal Prophylaxis","Invasive Fungal Disease","Prolonged Neutropenia","Hematological Malignancies","2026-08-08",{"date":312,"type":33},"2026-08-13",{"date":314,"type":33},"2025-08-01",{"date":316,"type":21},"2026-11-30",{"name":318,"class":40},"Haikou Affiliated Hospital of Central South University Xiangya School of Medicine",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":41},"100416851","phase-2-venetoclax-to-improve-outcomes-of-fractionated-busulfan-regimen-in-patients-with-high-risk-aml-and-mds-100416851","NCT04708054","Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS","Inclusion Criteria:\n\nPhase II\n\n1. Age ≥ 18 and ≤ 70 years. English and non-English speaking patients are eligible.\n2. Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:\n\n   1. ELN17 adverse risk prognostic group irrespective of remission status (see Appendix 2)\n   2. Measurable residual disease positive (MRD +)\n   3. Not in complete remission including complete remission without count recovery (Cri) and\u002For morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 3 for details.\n   4. AML secondary to MDS or MPD\n   5. Therapy-related AML.\n   6. Not in complete remission after one course of induction therapy\n\n   Or\n\n   Patients with myelodysplastic syndrome or CMML and one of the following high-risk features:\n   1. Poor or Very poor cytogenetic risk group as per IPSS-R\n   2. Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN1) or DNMT 3a or ASXL1 or RUNX1\n   3. Maximum IPSS-R \\>3.5 between diagnosis and the start of the preparative regimen.\n   4. ≥ 5% BM blasts at transplant\n   5. Therapy-related MDS\n3. HLA-identical sibling or a minimum of 7\u002F8 matched unrelated donor, or a haploidentical related donor available\n4. Subject must voluntarily sign an informed consent\n5. Female subjects of childbearing potential must have negative results for pregnancy test\n6. Adequate hepatic and renal function per local laboratory reference range as follows:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0X ULN\n   * Bilirubin \\\u003C1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n   * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n\nPhase III\n\n1. Age ≥ 18 and ≤ 65 years. English and non-English speaking patients are eligible.\n2. Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:\n\n   1. ELN22 adverse risk prognostic group irrespective of remission status (see Appendix\n   2. Measurable residual disease positive (MRD +) including MRD + any time after induction therapy.\n   3. Not in complete remission including complete remission without count recovery (Cri) and\u002For morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 4 for details.\n   4. AML secondary to MDS or MPD\n   5. Therapy-related AML.\n   6. Not in complete remission after one course of induction therapy\n   7. Second or higher complete remission\n\n   Or\n\n   Patients with myelodysplastic syndrome and one of the following high-risk features:\n   1. Poor or Very poor cytogenetic risk group as per IPSS-R\n   2. Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN11) or ASXL1 or RUNX1 or moderate high, or high, or very high-risk group as per IPSS-M\n   3. Maximum IPSS-R \\>3.5 between diagnosis and the start of the preparative regimen.\n   4. ≥ 5% BM blasts at transplant\n   5. Therapy-related MDS\n\n   Or\n\n   Patients with CMML\n3. HLA-identical sibling or a minimum of 7\u002F8 matched unrelated donor\n4. Subject must voluntarily sign an informed consent\n5. Female subjects of childbearing potential must have negative results for pregnancy test\n6. Adequate hepatic and renal function per local laboratory reference range as follows:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0X ULN\n   * Bilirubin \\\u003C1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n   * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n\nExclusion criteria:\n\n1. Subject is known to be positive for HIV.\n2. Subject has cognitive impairments and\u002For is a prisoner.\n3. Subject has acute promyelocytic leukemia\n4. Subject has known active CNS involvement with AML.\n5. 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. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: 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.\n6. Cardiac history of CHF requiring treatment or Ejection Fraction \\\u003C 50% or unstable angina;\n7. Corrected DLCO \\\u003C 50% or FEV1 \\\u003C65%.\n8. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n   * grapefruit or grapefruit products\n   * Seville oranges (including marmalade containing Seville oranges)\n   * star fruit\n9. Patients with cognitive impairments and\u002For any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.\n10. Prior allogeneic stem cell transplantation.","70 Years",{"count":327,"type":21},324,[83,329],"PHASE3","This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.",[86,332,28],"Chronic Myelomonocytic Leukemia","2026-08-07",{"date":335,"type":33},"2026-08-11",{"date":337,"type":33},"2021-10-21",{"date":339,"type":21},"2027-12-31",{"name":39,"class":40},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":41},"100651257","phase-1-allogeneic-inkt-cell-therapy-agent-797-after-sct-100651257","NCT07758218","Allogeneic iNKT Cell Therapy (agenT-797) After SCT","UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent\n* Adult patients anticipated to get an allogeneic hematopoietic cell transplantation (allo-SCT)\n* All donor types are accepted (MMUD \\[mismatched unrelated donor\\], MUD \\[matched unrelated donor\\], MSD \\[matched sibling donor\\], haploidentical)\n* All conditioning regimens will be accepted (MAC \\[myeloablative conditioning\\], RIC \\[reduced-intensity conditioning\\], NMAC \\[non-myeloablative conditioning\\])\n* Karnofsky Performance Scale (KPS) \\> 70\n* Eligible Diagnoses:\n\n  * Acute myeloid leukemia (AML) with intermediate\u002Fhigh-risk features or relapsed disease\n  * Chronic myeloid leukemia (CML) in accelerated or blast phases\n  * Myelodysplastic syndrome (MDS) with intermediate\u002Fhigh-risk features\n  * Acute lymphoblastic leukemia (ALL) with high-risk features or relapsed disease\n  * or any patients undergoing allogeneic stem cell transplant (allo-SCT) as standard of care could be eligible\n\nExclusion Criteria:\n\n* Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase",{"count":349,"type":21},22,[24],"The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are:\n\n* Is agenT-797 safe to use?\n* What medical problems do participants have when taking agenT-797?\n\nParticipants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.",[353,354,355,86,356,28],"Allogenic Stem Cell Transplantation","Myeloid Malignancies","Lymphoid Malignancies","Chronic Myeloid Leukemia","2026-08-05",{"date":335,"type":33},{"date":166,"type":21},{"date":361,"type":21},"2029-10",{"name":363,"class":40},"University of Wisconsin, Madison",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":41},"100538216","phase-1-225ac-dota-anti-cd38-daratumumab-monoclonal-antibody-with-fludarabine-melphalan-and-total-marrow-and-lymphoid-irradiation-as-conditioning-treatment-for-donor-stem-cell-transplant-in-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-and-myelodysplastic-syndrome-100538216","NCT06287944","225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome","Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* ≥ 70 years. Note: Patients ≥ 18 years and \\\u003C 70 years with active, relapsed or refractory, or high-risk acute leukemia or MDS as defined below.\n* Karnofsky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories :\n\n  * Acute myelogenous leukemia:\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups accept patients with FLT3-NPM1+ disease, OR\n    * Patients with a complete morphological remission (CR) with minimal residual disease (MRD)-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetic after at least 2 prior induction therapies, OR\n    * Patients with chemosensitive active disease defined as at least 50% reduction in their blast count after last treatment\n  * Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories per Revised International Prognostic Scoring System- (IPSS-R)\n  * Acute lymphocytic leukemia\n* Evidence of CD38 expression by flow cytometry AND one of the below\n\n  * Patients with de novo or secondary disease according to NCCN guidelines for ALL hypoploidy (\\\u003C 44 chromosomes); t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5 or more chromosomal abnormalities); high white blood cell (WBC) at diagnosis (≥ 30,000 for B lineage or ≥ 50,000 for T lineage); iAMP21loss of 13q, and abnormal 17p, OR\n  * Patients with a complete response (CR) with MRD-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetics after at least 2 prior induction therapies, OR\n  * Patients with chemosensitive active disease defined as at least 25% reduction in their blast count after last treatment\n  * Patients with myelofibrosis (primary or secondary, including post-polycythemia vera and post-essential thrombocythemia myelofibrosis) may be eligible for enrollment if they meet criteria for high-risk disease and are planned for allogeneic hematopoietic cell transplantation.\n* Eligible patients include those with:\n\n  * Accelerated-phase or blast-phase myelofibrosis, defined as 10% to 19% blasts or ≥20% blasts, respectively, in peripheral blood or bone marrow\n  * High-risk chronic-phase primary or secondary myelofibrosis, defined as disease meeting transplant-appropriate risk criteria by a validated MF prognostic model, including DIPSS intermediate-2 or high-risk; DIPSS-plus intermediate-2 or high-risk; MIPSS70 intermediate, high, or very high-risk; MIPSS70-plus or MIPSS70-plus version 2.0 intermediate, high, or very high-risk; GIPSS intermediate-2 or high-risk; or MYSEC-PM intermediate-2 or high-risk for post-polycythemia vera or post-essential thrombocythemia myelofibrosis. Patients may also qualify based on adverse clinical, cytogenetic, or molecular features supporting high-risk disease biology and transplant candidacy, including complex karyotype, monosomal karyotype, very high-risk karyotype, high molecular risk mutations, transfusion-dependent anemia, thrombocytopenia, circulating blasts, constitutional symptoms, or symptomatic splenomegaly despite standard therapy\n  * Suboptimal response, progression, or intolerance to prior JAK inhibitor therapy, defined as failure to achieve adequate spleen or symptom response after an appropriate trial of therapy, generally at least 12 weeks at an appropriate or maximally tolerated dose when clinically feasible; loss of prior spleen or symptom response; worsening splenomegaly; persistent or worsening constitutional symptoms attributable to MF; worsening cytopenias or transfusion dependence; progression to accelerated-phase or blast-phase disease; emergence of adverse cytogenetic or molecular features; or inability to continue JAK inhibitor therapy due to treatment-related toxicity. A minimum duration of JAK inhibitor exposure is not required when the treating investigator determines that continued therapy is not clinically appropriate due to rapidly progressive disease, accelerated-phase or blast-phase transformation, clinically significant cytopenias, intolerance, or urgent need to proceed to allogeneic HCT. The rationale for early determination of JAK inhibitor failure or inability to continue JAK inhibitor therapy will be documented in the medical record.\n  * Persistent disease burden, including persistent splenomegaly, circulating or marrow blasts, transfusion dependence, cytopenias attributable to MF, leukocytosis, thrombocytopenia, adverse cytogenetic or molecular features, extramedullary hematopoiesis, or progression despite standard therapy, may support high-risk classification but does not constitute a separate eligibility criterion unless the patient also meets the defined advanced-phase, validated risk-model, or JAK inhibitor failure criteria above.\n\n    \\*\\*See Appendix F: Defined Risk Scoring Systems in MF\n  * All patients must demonstrate CD38 expression on disease-relevant cell populations (bone marrow and\u002For peripheral blood) as assessed by flow cytometry or an equivalent validated assay prior to enrollment.\n\nClinical Laboratory and Organ Function Criteria (To be performed within 30 days prior to Day 1 of protocol therapy unless otherwise stated) or (acceptable windows for tests are indicated in the Study Calendar Section 10.0).\n\n* A pretreatment measured creatinine clearance (absolute value) of ≥ 60 ml\u002Fminute (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum bilirubin ≤ 2.0 mg\u002Fdl (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) ≥ 50% (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Forced expiratory volume in 1 second (FEV1) \\> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\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* DONOR SPECIFIC CRITERIA: All candidates for this study must have an human leukocyte antigen (HLA) (A, B, C, and DR) identical sibling who is willing to donate mobilized peripheral blood stem cells (preferred) or bone marrow, or have a 10\u002F10 (A, B, C, DR and DQ) allele matched unrelated donor. DQ or DP mismatch is allowed per discretion of the principal investigator. City of Hope (COH) standards of practice (SOP) (B.001.11) will be used for allogeneic donor evaluation, selection, and consent. Donor screening will be in compliance with all requirements of Food and Drug Administration (FDA) regulation 21 CFR Part 1271 including donor screening for COVID-19 exposure or infection\n\nExclusion Criteria:\n\n* Patients who had a prior allogeneic transplant\n* Patients who have had prior radiotherapy\n* Patients who have received prior radiopharmaceutical therapy\n* Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning\n* Patients should have discontinued all previous intensive therapy, chemotherapy, or radiotherapy for 2 weeks prior to commencing therapy on this study. Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). FLT-3 inhibitors can also be given up to 3 days before conditioning regimen\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancers\n* Patients should not have any uncontrolled illness including ongoing or active bacterial, viral or fungal infection\n* The recipient has a medical problem or neurologic\u002Fpsychiatric dysfunction which would impair his\u002Fher ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the investigator (treating physician) would place the recipient at unacceptable risk\n* Females only: Pregnant or breastfeeding\n* 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* 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)",{"count":372,"type":21},15,[24],"This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and\u002For effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.",[298,86,28],"2026-07-30",{"date":378,"type":33},"2026-07-31",{"date":380,"type":33},"2025-07-01",{"date":382,"type":21},"2028-05-19",{"name":196,"class":40},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":41},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":392,"type":21},27,[83],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,250,28,416,417,418,419,420,421,422],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Melanoma","Merkel Cell Carcinoma","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-07-28",{"date":376,"type":33},{"date":426,"type":33},"2025-12-18",{"date":428,"type":21},"2026-12-18",{"name":430,"class":40},"Mayo Clinic",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":41},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","15 Years","80 Years",{"count":440,"type":21},100,[83],"This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[444,445,298,446,447,448,449,450,332,451,452,453,454,28,455,456,457,458,112,459,460,461,462,463,464,465],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome",{"date":376,"type":33},{"date":468,"type":33},"2016-05-19",{"date":470,"type":21},"2027-05-31",{"name":39,"class":40},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":479,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":41},"100649649","phase-1-arsenic-trioxide-to-prevent-relapse-in-patients-undergoing-allogeneic-stem-cell-transplantation-for-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100649649","NCT07737769","Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase I Non-Randomized Study of TP53 Reactivation With Arsenic Trioxide in Allogeneic Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome","Inclusion Criteria:\n\n* AML or MDS patients eligible to receive first allogeneic HCT. Eligibility inclusion for HCT is defined as per University of Michigan bone marrow transplant (BMT) standard of care criteria\n* Presence of high-risk AML\u002FMDS with probable biallelic TP53 deletion or mutation status, defined by one of the following in prior blood or bone marrow assessments:\n\n  * TP53 loss by karyotype (chromosome 17 or 17p deletion) or single nucleotide polymorphism (SNP) (Cancer Microarray) AND ≥ one clonal TP53 mutation by next generation sequencing (NGS) (VAF \\> 10%).\n  * ≥ one TP53 mutation by NGS testing (with VAF \\> 40%)\n  * ≥ two distinct TP53 mutation(s) by NGS (VAF \\>10%)\n* Evidence that at least one TP53 allele harbors a structural TP53 missense mutation. In cases where the mutation type is unclassified, molecular pathology assessment is required to determine if one of the lesions is a missense mutation (as described in NGS report)\n* Patients may be enrolled with either active disease or in morphological remission, provided the bone marrow blast count on the pre-HCT assessment does not exceed 30%\n* Age \\> 21 years at enrollment and receiving allogeneic HCT in the adult transplant program\n* Karnofsky performance score (KPS) ≥ 70%\n* Documentation of adequate pulmonary function by forced expiratory volume and 1 second (FEV1) ≥ 50% of predicted, forced vital capacity (FVC) ≥ 50% of predicted and DLCO (corrected for hemoglobin) ≥ 50% of predicted (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Transthoracic echocardiogram with ejection fraction ≥ 50% (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Estimated glomerular filtration rate ≥ 50% ml\u002Fmin\u002F1.73m\\^2 by the Cockcroft-Gault equation. Glomerular filtration rate (GFR) should be corrected for body surface area (BSA) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Total bilirubin ≤ 2 x upper limit of normal (unless directly attributed to Gilbert's Syndrome) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Electrocardiogram (ECG) with corrected QT (QTc) ≤ 450 msec (using the Framingham correction) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Availability of an 8 of 8 HLA matched unrelated donor with matching at HLA A, B, C and DRB1\n* Availability of a peripheral blood stem cell (PBSC) product\n* Ability to understand and the willingness to sign a written informed consent\n* Willingness to agree to use adequate contraception methods (subjects of reproductive potential only):\n\n  * Females of reproductive potential must agree to use effective contraception (e.g., hormonal contraception, intrauterine device, tubal occlusion, vasectomized partner, abstinence) during treatment with ATO and for 6 months after the final dose.\n  * Males with female partners of reproductive potential must agree to use effective contraception during treatment with ATO and for 3 months after the final dose\n\nExclusion Criteria:\n\n* Uncontrolled infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and\u002For culture) that the infection is well controlled\n* Patients may NOT have evidence or symptoms of central nervous system (CNS) disease at the time of enrollment\n* HIV or human t-lymphotropic virus (HTLV) 1 \u002F HTLV 2 (seropositivity and\u002For polymerase chain reaction \\[PCR\\] positivity)\n* Pregnant and nursing mothers are excluded\n* Any physical, psychological or psychosocial condition that, in the opinion of the investigator, would pose unacceptable risk to the patient\n* Other malignancy requiring systemic therapy or with life expectancy of \\\u003C 1 year\n* Receipt of prior allogeneic HCT\n* History of severe cardiac conduction abnormalities (complete heart block, Left Bundle Branch Block, Torsades de Pointes, or other ventricular arrythmias). History of any cardiac arrhythmia (e.g. rate controlled atrial fibrillation) is not an exclusion\n* QTc \\> 450 msec (using the Framingham correction)\n* Patients under 40 years of age at time of evaluation will be screened for Shwachman-Diamond syndrome (SDS), which is a rare, inherited disorder characterized primarily by exocrine pancreatic insufficiency, bone marrow failure, and skeletal abnormalities. These patients commonly progress to myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Given potential for increased liver toxicities in this population, these patients will be excluded from the study. All patients under 40 years old will be screened through the University of Michigan Prevention Genetics Clinic prior to enrollment\n* Patients with known hypersensitivity to arsenic","21 Years",{"count":481,"type":21},20,[24],"This phase I trial tests the safety, side effects, best dose and how well arsenic trioxide works to prevent relapse in patients undergoing allogenic stem cell transplantation for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Chemotherapy drugs, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving arsenic trioxide may be safe, tolerable and\u002For effective in preventing relapse in patients undergoing allogenic stem cell transplant for AML or MDS.",[86,28],"2026-07-27",{"date":376,"type":33},{"date":488,"type":21},"2026-11",{"date":490,"type":21},"2029-11",{"name":492,"class":40},"University of Michigan Rogel Cancer Center",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},"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).",{"count":501,"type":21},46,[24],"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.",[505,298,86,300,506,408,410,507,28,508,228,509],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Lymphoblastic Lymphoma","Myelofibrosis","Non-Hodgkin Lymphoma",{"date":423,"type":33},{"date":512,"type":33},"2026-05-08",{"date":514,"type":21},"2029-05-30",{"name":196,"class":40},3,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":524,"phases":4,"briefSummary":525,"conditions":526,"keywords":530,"overallStatus":538,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":542,"locationsCount":4},"100619552","orca-t-expanded-access-program-study-for-patients-with-advanced-hematologic-malignancies-100619552","NCT07346105","Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies","An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release","Inclusion Criteria:\n\nRecipients in this EAP must meet all of the following criteria:\n\n1. Commercial Orca-T was prescribed to the patient by their treating physician.\n2. The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.\n3. The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.\n4. Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.\n5. Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.\n\nExclusion Criteria:\n\nRecipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.","EXPANDED_ACCESS","This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.",[527,86,528,28,529],"Hematologic Malignancies","Acute Lymphoid Leukemia","Mixed Phenotype Acute Leukemia",[531,532,533,534,535,536,537],"Hematopoietic stem cell transplantation","Acute leukemia","Myelodysplastic syndromes","Matched related donor","Matched unrelated donor","Myelodysplastic syndrome","TREGZI","AVAILABLE","2026-07-22",{"date":541,"type":33},"2026-07-24",{"name":543,"class":72},"Orca Biosystems, Inc.",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100625426","phase-3-a-study-to-compare-elritercept-with-epoetin-alfa-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100625426","NCT07422480","A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions","ELRiSE MDS","Inclusion Criteria\n\n1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.\n3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\\>) 14 days after red blood cell (RBC) transfusion or greater than (\\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.\n4. Bone marrow less than (\\\u003C) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.\n5. Endogenous serum erythropoietin s (EPO) level of \\\u003C500 U\u002FL. Should be results from blood samples collected \\>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.\n6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units\u002F8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.\n\n   • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g\u002FdL) (5.6 millimoles per liter (mmol\u002FL)) with symptoms of anemia (or ≤7 g\u002FdL \\[4.3 mmol\u002FL\\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.\n\n   • RBC transfusions administered when hemoglobin (Hgb) levels were \\>9.0 g\u002FdL (or \\>7 g\u002FdL in the absence of symptoms) and\u002For RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.\n7. Hgb \\\u003C11.0 g\u002FdL (6.8 mmol\u002FL) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.\n8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria\n\n\u003C!-- -->\n\n1. Prior therapy with any of the following:\n\n   1. Epoetin alfa\n\n      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.\n   2. Darbepoetin\n   3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.\n   4. Immunomodulatory drug (IMiDs) including lenalidomide\n\n      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.\n   5. Hypomethylating agent\n\n      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.\n   6. Luspatercept, sotatercept, imetelstat, or elritercept\n   7. Immunosuppressive therapy\n   8. Hematopoeitic cell transplant\n   9. Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n   10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed\n   11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.\n   12. Investigational agent or any other agent intended for treatment MDS treatment\n2. Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.\n3. Known history of diagnosis of acute myeloid leukemia (AML).\n4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.\n5. Clinically significant cardiovascular disease defined as:\n\n   1. New York Heart Association heart disease class III or IV\n   2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during screening\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening\n6. Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.\n7. 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 (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 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;\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n10. History of solid organ or bone marrow transplantation.\n11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.\n12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n13. Body mass index ≥ 40 kilograms per square meter (kg\u002Fm\\^2).\n14. Major surgery within 28 days before randomization.\n15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.\n16. History of allergy\u002Fanaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.\n17. History of pure red cell aplasia and\u002For antibody against erythropoietin (EPO).\n18. Any of the following laboratory abnormalities:\n\n    1. ANC \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002FL).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or ≥450,000\u002FμL (450×109\u002FL).\n    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).\n    4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \\\u003C3×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    5. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.\n    6. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    7. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    8. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n19. Ongoing participation in another interventional clinical trial.\n20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.\n21. Is a participant of childbearing potential (POCBP) 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 trial intervention.\n22. 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 trial intervention period until at least 60 days after the last dose of trial intervention.\n23. 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 trial intervention period until at least 60 days after the last dose of trial intervention.\n24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":553,"type":21},300,[329],"The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.",[28,557],"Anemia",[559,560],"TAK-226","Drug therapy","2026-07-21",{"date":539,"type":33},{"date":564,"type":33},"2026-05-21",{"date":566,"type":21},"2033-10-01",{"name":568,"class":72},"Takeda",156,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":582,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100379997","phase-1-a-safety-study-of-sea-cd70-in-patients-with-myeloid-malignancies-100379997","NCT04227847","A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies","A Phase 1 Study of SEA-CD70 in Myeloid Malignancies","Part A Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (2016 World Health Organization (WHO) classification) with\n\n  * Measurable disease per WHO MDS with excess blasts criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nPart B Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (WHO classification) with:\n\n  * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior HMA therapy for MDS\n* ECOG Performance Status of 0-2\n\nPart C Inclusion Criteria\n\n* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \\[APL\\]):\n\n  * Who have received either 2 or 3 previous regimens\n  * Who have received 1 previous regimen to treat active disease and have at least one of the following:\n\n    * Age \\> 60 and ≤75 years.\n    * Primary resistant AML or secondary AML\n    * First CR duration \\\u003C6 months\n    * Adverse-risk per European Leukemia Network genetic risk stratification\n* Age 18-75 years\n* ECOG performance status of 0-2\n\nParts D and F Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria)\n* Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.\n* Eligible for continued therapy with azacitidine\n* ECOG Performance Status 0-2\n\nParts D and E Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria), previously untreated.\n* Participants with higher-risk per IPSS-M MDS and MDS\u002FAML\n* ECOG Performance Status 0-2\n\nPart G Inclusion Criteria\n\n* Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.\n* Age ≥18 years.\n* ECOG Performance Status of 0-2.\n\nExclusion Criteria (All Parts)\n\n* Previous exposure to CD70-targeted agents\n* Prior allogeneic hematopoietic stem cell transplant, for any condition\n* Central nervous system leukemia\n* History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura\n* Parts D, F and G only: Prior oral HMA or oral HMA-combinations\n* Part G: conditions that preclude enteral route of administration; concomitant use of strong\u002Fmoderate CYP3A inducers; history of myeloproliferative neoplasm",{"count":578,"type":21},178,[24],"This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer.\n\nThis study will have seven groups or \"parts.\"\n\n* Part A will find out how much SEA-CD70 should be given to participants\n* Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS.\n* Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML.\n* Part D will find out how much SEA-CD70 with azacitidine should be given to participants\n* Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML that has not been treated.\n* Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML.\n* Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.",[28,86],[583],"Seattle Genetics",{"date":539,"type":33},{"date":586,"type":33},"2020-08-07",{"date":588,"type":21},"2028-07-03",{"name":590,"class":72},"Seagen, a wholly owned subsidiary of Pfizer",53,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":599,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":41},"100517121","phase-2-cord-blood-transplant-cyclophosphamide-fludarabine-and-total-body-irradiation-in-treating-patients-with-high-risk-hematologic-diseases-100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","6 Months","65 Years",{"count":272,"type":21},[83],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[605,298,86,606,408,529,28,228,509,607],"Acute Leukemia of Ambiguous Lineage","Blastic Plasmacytoid Dendritic Cell Neoplasm","Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-07-20",{"date":539,"type":33},{"date":611,"type":33},"2024-07-23",{"date":613,"type":21},"2032-10-31",{"name":615,"class":40},"Fred Hutchinson Cancer Center",{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":41},"100596485","phase-2-combination-chemotherapy-flag-ida-followed-immediately-by-reduced-intensity-total-body-radiation-therapy-and-donor-hematopoietic-cell-transplant-for-the-treatment-of-adults-age-60-and-older-with-newly-diagnosed-adverse-risk-acute-myeloid-leukemia-or-other-high-grade-myeloid-cancer-100596485","NCT07046078","Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer","Pilot Study of FLAG-Ida Followed Immediately by Reduced-Intensity Allogeneic HCT for Adults Age 60 and Older With Newly Diagnosed Adverse-Risk AML or Other High-Grade Myeloid Neoplasm","Inclusion Criteria:\n\n* PARTICIPANTS: Age ≥ 60 years. Adults age \\\u003C 60 years are eligible if they are felt to be unsuitable candidates for myeloablative conditioning as per physician assessment\n* PARTICIPANTS: Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants\n* PARTICIPANTS: Newly diagnosed, untreated high-risk myeloid or mixed myeloid\u002Flymphoid neoplasm:\n\n  * Adverse-risk AML (using 2022 International Consensus Classification for disease categorization and 2022 European LeukemiaNet \\[ELN\\] criteria for molecular\u002Fcytogenetic risk assignment)\n  * Acute leukemia of ambiguous lineage (using 2022 International Consensus Classification for disease categorization)\n  * High-risk myelodysplastic neoplasm (MDS) (Molecular International Prognostic System \\[IPSS-M\\] moderate high, high, or very high, OR ≥ 10% blasts in blood or marrow)\n  * High-risk chronic myelomonocytic leukemia (CMML) (clinical\u002Fmolecular CMML-specific prognostic scoring system \\[CPSS-Mol\\] intermediate-2 or high, OR ≥ 10% blasts in blood or marrow)\n\n    * Prior treatment of MDS or CMML with lower-intensity therapy (e.g., growth factors, erythropoiesis-stimulating agents, and lenalidomide) is permissible, but patients may not have received prior hypomethylating agents\n* PARTICIPANTS: Disease not requiring immediate anti-neoplastic therapy (e.g., presenting with leukopenia or pancytopenia), defined as a clinical scenario in which delay of systemic leukemia-directed treatment would be unsafe. Supportive cytoreduction with hydroxyurea for transient disease control is allowed, and does not constitute immediate anti-neoplastic treatment\n* PARTICIPANTS: Interest in pursuing allogeneic HCT\n* PARTICIPANTS: Available caregiver\n* PARTICIPANTS: Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* PARTICIPANTS: Bilirubin ≤ 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by myeloid neoplasm, Gilbert's syndrome, or hemolysis\n* PARTICIPANTS: Serum creatinine ≤ 1.5 mg\u002FdL\n* PARTICIPANTS: Prior autologous HCT is permissible if \\> 6 months after planned HCT on this study\n* PARTICIPANTS: Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception 7 days before initiation of study treatment and for at least 12 months after HCT. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening (within 2 weeks of treatment initiation, per Fred Hutch Cancer Center \\[FHCC\\] standard of care \\[SOC\\]), where WOCBP are defined as all female participants between 18-55 years of age, unless postmenopausal or with hysterectomy\n* PARTICIPANTS: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* PARTICIPANTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load\n* PARTICIPANTS: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, as determined by the investigator, are eligible for this trial\n* DONORS: Patients must have an HLA-matched related donor, an HLA-matched or mismatched unrelated donor, or an HLA- haploidentical donor who meets standard Fred Hutchinson Cancer Center (FHCC) and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation as follows:\n\n  * HLA-matched related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing\n  * HLA-matched unrelated donor:\n\n    * 10\u002F10 matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * HLA-mismatched unrelated donor:\n\n    * HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch\n    * Donor\u002Frecipient HLA mismatching at loci for which the patient is homozygous is not allowed (isolated rejection vector)\n  * HLA-haploidentical donor:\n\n    * Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n\n      * Donor age ≥ 12 years\n      * Donor weight ≥ 40 kg\n      * Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival\n      * Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n    * In case of more than one available haploidentical donor, preference should be given to younger age\n    * Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Use of donors requiring desensitization treatment of the patient are not permissible\n\nExclusion Criteria:\n\n* PARTICIPANTS: Active central nervous system (CNS) disease\n* PARTICIPANTS: Decompensated congestive heart failure and\u002For uncontrolled arrhythmia and\u002For significant medical history of cardiac disease precluding allogeneic HCT\n* PARTICIPANTS: Significant medical history of pulmonary disease and\u002For symptoms suggestive of pulmonary disease precluding allogeneic HCT\n* PARTICIPANTS: Treatment with any other approved or investigational anti-leukemia agent(s) at the time of initiation of study treatment\n* PARTICIPANTS: Concomitant illness associated with a likely survival of \\\u003C 1 year\n* PARTICIPANTS: Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be secondary to myeloid malignancy are eligible\n* PARTICIPANTS: Known hypersensitivity or contraindication to receiving any of the study drugs used in this trial, including post-transplant cyclophosphamide (PTCy)\n* PARTICIPANTS: Pregnancy or lactation\n* PARTICIPANTS: Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":481,"type":21},[83],"This phase II trial tests the safety, side effects, and how well combination chemotherapy with fludarabine, high-dose cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin (FLAG-Ida) followed immediately by reduced-intensity total body radiation therapy, called total body irradiation (TBI), and donor hematopoietic cell transplant (HCT) works in treating adults age 60 and older with newly diagnosed adverse-risk acute myeloid leukemia (AML) or other high-grade myeloid cancer. Despite advances in supportive care and the approval of more than 10 new drugs since 2017, the outcomes of older adults with adverse-risk acute myeloid leukemia and other high-grade myeloid cancers remains poor. Most patients are expected to die from their cancer or the consequences of treatment-related side effects. Donor HCT is a very important part of any curative-cancer treatment for these patients. However, while accepted as standard care for decades, this treatment exposes patients to long periods of drug-induced low blood cell counts and the problems associated with low blood counts, like infections and bleeding, which are associated with significant risk of chronic side effects and death. This study will use a different approach to the upfront curative-cancer treatment of older adults with an adverse-risk AML or other high-grade myeloid cancer. This study will use intense chemotherapy followed a few days later by lower-dose TBI and donor HCT. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. This approach allows effective treatment of cancer cells and overall reduction of the period of low blood cells counts. This decreases the risk for problems associated with low blood counts, such as infection and chronic side effects. Decreasing these are important for older adults who undergo HCT. This treatment strategy may improve treatment outcomes by allowing more patients to successfully undergo donor HCT and reduce the risk of low blood cell counts and the problems associated with low blood counts. Giving chemotherapy followed immediately by reduced-intensity TBI and donor HCT may be safe, tolerable and\u002For effective in treating adults age 60 and older with newly diagnosed adverse-risk AML or other high-grade myeloid cancer.",[605,86,332,28],"2026-07-17",{"date":608,"type":33},{"date":630,"type":33},"2025-09-26",{"date":632,"type":21},"2029-06-30",{"name":615,"class":40},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":41},"100554429","phase-1-tagraxofusp-and-azacitidine-for-maintenance-treatment-in-patients-with-cd123-positive-aml-and-mds-following-donor-hematopoietic-cell-transplant-100554429","NCT06498973","Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant","CD123 Antibody Toxin Congregate (CD123 ATC; Tagraxofusp) Combined With Azacitidine for Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for Patients With CD123-Positive Malignant","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: 18-75 years old\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* First or second allogeneic HCT-eligible patients with AML or MDS with high-risk cytogenetics per European LeukemiaNet (ELN) (AML) or Revised International Prognostic Scoring System (R-IPSS) (MDS); or by having active (morphological) or minimal residual disease (MRD)+ status at the time of HCT (by multicolor flowcytometry, cytogenetics or molecular testing) OR patients who underwent HCT for AML or MDS with high-risk cytogenetics per ELN (AML) or R-IPSS (MDS)\n* Positive for CD123 by flow cytometry of either peripheral blood or bone marrow aspirates at the time of diagnosis at any time-point prior to HCT. (Note: CD123 measurement will be conducted using the 10-color Beckman Coulter Navios XL flow cytometer. We will use CD123 PE \\[Beckman Coulter #A32535\\] to gate the abnormal population of interest. This population will be compared to the internal negative control population \\[e.g., T-cells\\]. If more than 20% of the abnormal population is positive relative to this control, it will be classified as positive.)\n* Any conditioning regiment or GVHD prophylaxis is allowed\n* Any donor (i.e., match related\u002Funrelated, mismatched, haploidentical, etc.) or graft source (i.e., bone marrow, mobilized peripheral blood stem cells, etc.) is allowed\n* Prior treatment with CD123-therapy is allowed if no progression is documented on therapy\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\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* STUDY MAINTENANCE TREATMENT: Complete response (CR) or MRD-positive on day 30 bone marrow biopsy (BMB) for disease assessment\n* STUDY MAINTENANCE TREATMENT: Patients must be fully engrafted after HCT before starting the first cycle of maintenance. Full engraftment is defined as absolute neutrophil count (ANC) of 500 or above for 3 days and platelet count of more than 20,000 without transfusion for 7 consecutive days\n* STUDY MAINTENANCE TREATMENT: ECOG ≤ 2\n* STUDY MAINTENANCE TREATMENT: No treatment with anti-CD123 therapy after allogeneic HCT\n* STUDY MAINTENANCE TREATMENT: No evidence of active or uncontrolled infection\n* STUDY MAINTENANCE TREATMENT: No active GVHD; prednisone dose of ≤ 10 mg\u002Fdaily is allowed\n* STUDY MAINTENANCE TREATMENT: ANC ≥ 1.5 (within 7 days of day 1 of the cycle 1)\n\n  * NOTE: Transfusion (red blood cells \\[RBC\\] or platelet) to achieve the above-mentioned counts is allowed\n* STUDY MAINTENANCE TREATMENT: Hemoglobin (HbG) ≥ 7 (within 7 days of day 1 of the cycle 1)\n\n  * NOTE: Transfusion (RBC or platelet) to achieve the above-mentioned counts is allowed\n* STUDY MAINTENANCE TREATMENT: Platelet count ≥ 20K (within 7 days of day 1 of the cycle 1)\n\n  * NOTE: Transfusion (RBC or platelet) to achieve the above-mentioned counts is allowed\n* STUDY MAINTENANCE TREATMENT: Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 7 days of day 1 of the cycle 1)\n* STUDY MAINTENANCE TREATMENT: Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 7 days of day 1 of the cycle 1)\n* STUDY MAINTENANCE TREATMENT: Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 7 days of day 1 of the cycle 1)\n* STUDY MAINTENANCE TREATMENT: Serum albumin \\> 3.2 (within 7 days of day 1 of the cycle 1) (note that albumin infusions are not permitted in order to enable eligibility but can be given after treatment starts)\n* STUDY MAINTENANCE TREATMENT: Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 7 days of day 1 of the cycle 1)\n* STUDY MAINTENANCE TREATMENT: If not receiving anticoagulants: International normalized ratio (INR) or prothrombin (PT) ≤ 1.5 x ULN (within 7 days of day 1 of the cycle 1)\n\n  * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* STUDY MAINTENANCE TREATMENT: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 7 days of day 1 of the cycle 1)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* STUDY MAINTENANCE TREATMENT: The Patient should agree to use acceptable contraceptive methods for the duration of the time in the study, and to continue to use contraceptive methods for 6 months following the end of study therapy\n* STUDY MAINTENANCE TREATMENT: The patient may not have persistent clinically significant toxicities grade ≥ 1 from previous therapies, including cytotoxic chemotherapy, targeted therapies, biological therapies, or immunotherapies, not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue)\n* STUDY MAINTENANCE TREATMENT: The patient has not received treatment with another investigational agent within 14 days of study entry\n* STUDY MAINTENANCE TREATMENT: The patient does not have clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)\n* STUDY MAINTENANCE TREATMENT: The patient does not have uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study\n* STUDY MAINTENANCE TREATMENT: The patient does not have known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and\u002For examination of cerebrospinal fluid\n* STUDY MAINTENANCE TREATMENT: The patient does not have uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* STUDY MAINTENANCE TREATMENT: The patient does not have any condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (tagraxofusp and azacitidine)\n* Females only: Pregnant or breastfeeding\n* Any other condition including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness, 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* The patient has an active malignancy and\u002For cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) with substantial potential for recurrence and\u002For ongoing active malignancy must be discussed with the sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease\n* The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)\n* The patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study\n* The patient has known active or suspected central nervous system (CNS) disease. If suspected, CNS disease should be ruled out with relevant imaging and\u002For examination of cerebrospinal fluid\n* Active hepatitis B or C or HIV infection\n* The patient has any condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities\n* 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)",{"count":642,"type":21},43,[24],"This phase Ib trial tests the safety, side effects, best dose and effectiveness of tagraxofusp in combination with azacitidine as maintenance therapy in treating patients with CD123 positive acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after a donor (allogeneic) hematopoietic cell transplant. An allogeneic hematopoietic cell transplant (HCT) is a type of transplant where the cancer patient receives cells from another person. Maintenance therapy is given after the transplant to prevent the cancer from coming back. Tagraxofusp is a drug that targets cells that have CD123 on their surface in order to kill the cancer cells to help prevent the cancer from coming back. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving tagraxofusp in combination with azacitidine may be safe, tolerable and\u002For effective maintenance therapy in patients with CD123 positive AML and MDS after an allogeneic HCT.",[86,28],"2026-07-15",{"date":648,"type":33},"2026-07-16",{"date":650,"type":33},"2025-01-28",{"date":652,"type":21},"2027-04-25",{"name":196,"class":40},{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":41},"100440040","phase-1-astx727-venetoclax-and-gilteritinib-for-the-treatment-of-newly-diagnosed-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100440040","NCT05010122","ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults \\>= 18 years with newly diagnosed FLT3-mutated AML. Patients should meet the following criteria:\n\n    * Confirmed newly diagnosed AML with FLT3 mutation\n    * Ineligible for induction therapy defined as\n\n      * Either age \\>= 75\n      * Or 18-74 with at least one comorbidity (congestive heart failure \\[CHF\\] requiring therapy or ejection fraction \\[EF\\] =\\\u003C 50%, diffusion capacity of the lung for carbon monoxide \\[DLCO\\] =\\\u003C 65% or forced expiratory volume in 1 second \\[FEV1\\] =\\\u003C 65%, or Eastern Cooperative Oncology Group \\[ECOG\\] 2 or 3, or other significant co-morbidity precluding use of cytotoxic chemotherapy as approved by the principal investigator (PI)\n  * Phase II cohort B: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or MDS that is intermediate-2 or high-risk by the International Prognostic Scoring System who have received 1 prior therapy\n  * For all cohorts, patients with either FLT3-ITD or FLT3 D835 mutations will be eligible\n* Performance status =\\\u003C 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin =\\\u003C 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n* Hydroxyurea or one dose of cytarabine up to 1000 mg is allowed to reduce the white blood cell (WBC) to less than 25 x 10\\^9\u002FL prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior therapies\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed including prior hypomethylating agent (HMA) therapy for MDS. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: Patients with \\>= 3 prior lines of therapy are not eligible. Stem cell transplantation, treatment given only for cytoreductive purposes (e.g. hydroxyurea), and growth factors do not count as lines of therapy for this purpose. Prior therapy with venetoclax and gilteritinib is allowed\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT (QTc) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association Criteria\n* Active central nervous system leukemia\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of CYP3A or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted. Use of hydroxyurea or one dose cytarabine to reduce WBC below 25 prior to initiation of study treatment is recommended\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to use effective methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib\n* Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study",{"count":20,"type":21},[24,83],"This phase I\u002FII trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.",[86,28,112,114],"2026-07-14",{"date":648,"type":33},{"date":668,"type":33},"2021-07-08",{"date":670,"type":21},"2028-01-30",{"name":39,"class":40}]