[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml---acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml---acute-myeloid-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,82,110,141,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636507","phase-1-dose-finding-study-to-evaluate-the-safety-of-bsb-2002-in-relapsed-or-refractory-acute-myeloid-leukemia-aml-patients-with-npm1-mutation-100636507",false,"NCT07566585","Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","A Phase 1 Multicenter Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation","Inclusion Criteria:\n\n1. Male or female patients, ages 18 years or older,\n2. AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,\n\n   1. which is relapsed (after previously complete remission, CR, CRh or CRi), or\n   2. refractory (failed to achieve complete remission) to the last treatment\\*, \\*Primary refractory patients should have received at least two cycles of induction treatment\n3. Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment\n4. HLA-A\\*02:01,\n5. Positive for NPM1 mutation type A, D, G or H (see Appendix 3)2\n6. Adequate venous access for apheresis or agree to use of a central line for apheresis collection,\n7. Willing and able to provide informed consent and adhere to all study requirements.\n\nExclusion Criteria:\n\n1. Leukemic blast count of \\>20,000\u002Fμl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.\n2. Patients with extramedullary only AML.\n3. Patients that are candidates for hematopoietic stem cell transplant.\n4. Patients that are eligible to receive an approved targeted therapy.\n5. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-2002 (day 1).\n6. Subject has had hematopoietic stem cell transplant (HSCT) and has any of the following:\n\n   1. Is within 3 months of transplant;\n   2. Has clinically significant graft-versus-host disease requiring systemic treatment;\n   3. Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant.\n7. Other malignancy that requires treatment.\n8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.\n9. Active Hepatitis B or C infection.\n10. Seropositive for Human Immunodeficiency Virus-1 or -2.\n11. CNS involvement refractory to intrathecal chemotherapy and\u002For standard cranial- spinal radiation.\n12. Subject has congestive heart failure NYHA class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless an echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%.\n13. Renal insufficiency, with estimated creatinine clearance of \\\u003C 40 ml\u002Fmin\u002F1.73m2 by the Cockcroft-Gault equation with adjustment if the weight is ≥ 125% of ideal body weight OR inadequate renal function defined by serum creatinine \\> 1.6 mg\u002FdL\n14. Total bilirubin \\> 2x upper limit of normal (unless attributed to Gilbert's Syndrome).\n15. AST or ALT \\> 3x upper limit of normal.\n16. Pregnant or lactating women.\n17. Eastern Cooperative Oncology Group (ECOG) performance status \\>2.\n18. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids at any dose)\n19. Women of childbearing potential (WOCBP) and men who are fertile and are unwilling to use an effective birth control method or abstinence for 12 months. Effective forms of birth control are listed in the Contraception section.\n20. Any condition, in the judgement of the Investigator, that would interfere with study participation, pose a significant risk to the patient, or interfere with study data interpretation.","ALL","18 Years",{"count":19,"type":20},19,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your cancer.",[26,27,28],"AML - Acute Myeloid Leukemia","AML With Mutated NPM1","AML, Adult Recurrent",[30,31],"TCR","T-cell therapy","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2026-04-21",{"date":40,"type":20},"2027-09",{"name":42,"class":43},"BlueSphere Bio, Inc","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100592534","phase-1-a-study-of-cbx-250-in-participants-with-relapsed-or-refractory-myeloid-leukemias-100592534","NCT06994676","A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias","CROSSCHECK-001","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Dose Escalation: Male or female participants aged ≥18 years.\n2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available.\n\n   Diagnosis \\& Disease Characteristics\n3. Participants with histological confirmation of advanced hematologic malignancy including:\n\n   1. R\u002FR AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \\[Dohner 2022\\]; after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible.\n   2. R\u002FR HR-MDS or very high risk MDS as per the Revised International Prognostic Scoring System (IPSS-R; Greenberg 2012) or Molecular International Prognostic Scoring System (IPPS-M, Bernard 2022) who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n   3. R\u002FR CMML who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n\n   Performance Level\n6. ECOG PS score 0-1 (if aged ≥18 years); Karnofsky Performance Scale of ≥70 (if aged ≥16 years and \\\u003C18 years); Lansky PS of ≥70 (if aged \\\u003C16 years).\n\n   Prior Therapy\n7. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia.\n8. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n9. Stem Cell Infusion: At least 60 days must have elapsed from HSCT and at least 4 weeks (from first dose) must have elapsed from donor lymphocyte infusion without conditioning.\n10. Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy.\n11. Anti-Leukemia Therapy: At least 14 days since the completion of anti-leukemic therapy (for example, but not limited to, small molecule or cytotoxic\u002Fmyelosuppressive therapy), with the following exceptions:\n\n    * Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea for cytoreduction can be continued concomitantly with CBX-250, with Study Responsible Physician approval.\n    * Intrathecal chemotherapy at the time of diagnostic lumbar puncture at least 24 hours prior to the start of CBX-250 and may continue prophylactic intrathecal chemotherapy beginning in Cycle 2, at the treating physician's discretion.\n12. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n13. Biologics (e.g. monoclonal antibody therapy): At least 28 days or 5 half-lives, whichever is shorter, have elapsed since the completion of therapy with a biologic agent. Any AE related to prior biologic treatment must be resolved to baseline severity or ≤Grade 1.\n14. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n\n    Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n15. Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric participants or Cockcroft-Gault formula for adults).\n\n    1. Participants ≥18 years: glomerular filtration rate ≥45 mL\u002Fmin\n    2. Participants \\\u003C18 years: ≥45 mL\u002Fmin x (participant's body surface area m2\u002F1.73) • Adequate liver function defined as:\n\n       * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n       * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic involvement with discussion with the Study Responsible Physician).\n\n    Sex and Contraceptive\u002FBarrier Requirements\n16. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n17. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n\n    Informed Consent\n18. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nDiagnosis\n\n1. Previous CTSG targeted therapy or treatment with any pMHC T-cell engager.\n2. Isolated extramedullary relapse.\n3. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy).\n\n   Infection\n4. Known HIV infection.\n5. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n6. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n\n   Pregnancy and Breastfeeding\n7. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   Concurrent Conditions\n8. Cardiac Disease:\n\n   * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n   * QTc using Fridericia's correction (QTcF) \\>480 msec\n9. Graft-Versus-Host Disease (GVHD): Active acute or chronic GVHD requiring systemic treatment with immunosuppressive medication. Participants may be on physiological doses of steroids.\n10. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n11. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n\n    Concomitant Medications and Interventions\n12. Any commercially available or investigational anti-leukemic therapy other than CBX-250, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n13. Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 14 days or 5-halflives, whichever is shorter, of starting CBX-250. Participants may continue with non-interventional follow-up from previous clinical studies.\n14. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted.\n15. Known allergy or sensitivity to study drug, including excipients.","12 Years",{"count":55,"type":20},72,[23],"Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed\u002Frefractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.",[59,60,26,61],"High-risk Myelodysplastic Syndrome","Chronic Myelomonocytic Leukemia (CMML)","Chronic Myeloid Leukemia",[63,64,65,66,67,68,69,51,70,71],"AML","HR-MDS","CMML","acute leukemia","CBX-250","CBX-250-001","CROSSCHECK","Crossbow","CML","2026-03-12",{"date":74,"type":36},"2026-03-16",{"date":76,"type":36},"2025-07-16",{"date":78,"type":20},"2027-06",{"name":80,"class":43},"Crossbow Therapeutics, Inc.",11,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100576259","evaluation-of-combined-sensitising-and-hypomethylating-therapy-outcomes-in-aml-pdx-100576259","NCT06782971","Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX","COSMOS-Avatar: Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX","COSMOS-Avatar","Inclusion Criteria:\n\n1. Age 18 years and above\n2. Patients with suspicion of AML requiring screening procedures\n3. Documented diagnosis of AML by WHO Classification and\u002For International Consensus Classification.\n\n   * Regardless of the number and type of prior lines of therapy or eligibility for allogeneic stem cell transplantation.\n   * All AML subtypes are eligible.\n   * Concurrent participation in clinical trials is allowed.\n4. Documented myeloblast percentage ≥20% in the bone marrow or peripheral blood within 12 weeks of C1D1 confirmed by bone marrow aspirate or peripheral blood smear.\n5. Planned to commence venetoclax and azacitidine therapy.\n6. Provision of written informed consent prior to any study-related assessments or procedures being carried out.\n\nExclusion Criteria:\n\n1\\. Presence of any condition that, by assessment of the Investigator, would compromise the safety of the patient if they participated, the quality of trial data, or their adherence to the study-specified procedures.",{"count":91,"type":20},25,"OBSERVATIONAL","The goal of this observational study is to develop new ways to test new drug combinations to kill tumour cells, in patients with acute myeloid leukemia (AML). The main questions it aims to answer are:\n\n* Are there new ways to speed up discovery of better treatments for AML patients using AML cells from individual from patients in special mice that can accept human tissue?\n* Do these mice show treatment responses that are similar to the individual AML patient from whom cells were derived?\n\nParticipants with AML who are taking standard of care treatment of venetoclax and azacitidine will be asked to donate blood and bone marrow samples for this study.",[26],[63,96,97,98],"Acute Myeloid Leukemia","PDX","Patient-derived xenografts","2025-12-04",{"date":101,"type":36},"2025-12-08",{"date":103,"type":36},"2025-06-06",{"date":105,"type":20},"2030-03",{"name":107,"class":108},"Clinical Hub for Interventional Research (CHOIR)","OTHER_GOV",4,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100608451","early-phase-1-cd123cll-1-car-t-sequential-infusion-with-cd7-car-t-and-bridging-to-allo-hsct-for-relapsedrefractory-acute-myeloid-leukemia-100608451","NCT07201727","CD123+CLL-1 CAR-T Sequential Infusion With CD7 CAR-T and Bridging to Allo-HSCT for Relapsed\u002FRefractory Acute Myeloid Leukemia","Early Clinical Study of CD123+CLL-1 Dual-target CAR-T Cells Sequential Infusion CD7 CAR-T Cells and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\nPatients must meet all of the following criteria：\n\n* Patients are clinically diagnosed with relapsed or refractory acute myeloid leukemia；\n* Tumor cells are confirmed to be CD123 or CLL-1 positive by flow cytometry (FCM) or immunohistochemistry, with a positivity rate of no less than 80%；\n* Patients aged 18 to 75 years (inclusive)；\n* The expected survival time is more than 3 months from the date of signing the informed consent;\n* KPS≥80 points;\n* The functions of vital organs need to meet the following conditions: ①LVEF\\>50%，and electrocardiogram is normal; ② Oxygen saturation ≥90%;③ SCr≤2.5ULN；④ALT and AST≤5ULN，TBil≤3ULN；\n* Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.\n* The subject or guardian understands and signs the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\nAny of the following conditions will not be eligible for enrolment in this study:\n\n* Within one - year prior to signing the informed consent form, there is a history of heart failure of New York Heart Association (NYHA) class ≥ III, or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other cardiac diseases with prominent clinical symptoms, or the QTc interval is \\> 480 ms during screening (the QTc interval is calculated by the Fridericia formula);\n* Those with active GvHD or those who need to use immunosuppressants;\n* Patients who have had any malignancy other than acute myeloid leukemia (AML) within the past 5 years, except for those with adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally resected prostate cancer, or resected ductal carcinoma in situ of the breast;\n* Patients who have active infections requiring systemic treatment or uncontrollable infections within 7 days prior to screening, except for mild urinary and genital infections and upper respiratory infections;\n* There has been a history of autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) that require systemic immunosuppressive\u002Fsystemic disease regulatory drugs for treatment within the past two years;\n* When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded. If the hepatitis C virus (HCV) antibody is positive, those with positive HCV RNA in peripheral blood need to be excluded. Those who are positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for cytomegalovirus (CMV) DNA; Those with positive DNA test for lymphotropic human herpesvirus (EBV); Those who test positive for Treponema pallidum specific antibody (TPPA) need to be excluded;\n* Participation in another clinical trial within 4 weeks or within 5 half-lives of the last dose of the drug from the previous clinical trial (whichever is longer);\n* Has a history of severe allergy to biological products;\n* Unstable systemic diseases as judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring medical treatment;\n* Pregnant or lactating women, female subjects who plan to become pregnant within 2 years after CAR-T cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their CAR-T cell infusion;\n* conditions that the investigator believes may increase the risk to the subject or interfere with the results of the trial.","75 Years",{"count":119,"type":20},10,[121],"EARLY_PHASE1","This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.",[26],[96,125,126,127,128,129,130],"CAR-T","Allogeneic hematopoietic stem cell transplantation","CD7","CD123","CLL1","CD123+CLL1","NOT_YET_RECRUITING","2025-09-30",{"date":134,"type":36},"2025-10-01",{"date":132,"type":20},{"date":137,"type":20},"2028-07-01",{"name":139,"class":140},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":109},"100594928","phase-2-evaluation-of-treosulfan-versus-melphalan-conditioning-followed-by-ptcy-in-patients-with-aml-and-mds-undergoing-allogeneic-transplantation-100594928","NCT07025824","Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation","Randomized Evaluation of Treosulfan Versus Melphalan Conditioning Followed by PTCy in Patients With AML and MDS Undergoing Allogeneic Transplantation","RELEVANT","Main Inclusion Criteria:\n\n1. Informed consent signed by the patient capable of giving\n2. Patient scheduled for allogeneic transplantation within the next 3 weeks\n3. Age ≥ 18 years\n4. AML or MDS according to WHO with indication for allogeneic HCT:\n\n   1. AML in first or second complete remission (CR) or complete remission with incomplete hematologic recovery (CRi\u002FCRh) or morphologic leukemia-free state (MLFS)\n   2. MDS according to WHO\n5. Increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria:\n\n   1. Patients aged ≥ 50 years at transplant and\u002For\n   2. HCT-CI \\> 2 and\u002For\n   3. AML or MDS scheduled for 2nd allogeneic HCT from different donor with minimum of 12 months after 1st allogeneic HCT\n6. Availability of a suitable donor:\n\n   1. Matched sibling donor (MSD) or\n   2. matched unrelated donor (MUD, 10\u002F10 HLA) or\n   3. mismatched unrelated donor (MMUD, single allele or antigen mismatch at HLA-A, -B, -C, or -DRB1 and no concurrent -DQB1 mismatch (9\u002F10) shown by confirmatory typing) or\n   4. haploidentical family donor\n7. Planned GvHD prophylaxis with standard PTCy (with 50mg\u002Fkg body weight on days +3 and +4)\n8. No history of cardiac disease that preclude allogeneic HCT and absence of active symptoms, otherwise, documented left ventricular ejection fraction\n\n   * 40 %.\n9. No need for supplementary oxygen on day of randomization\n\nMain Exclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia with t(15;17)(q22;q12)\n2. Patients with graft failure after previous allogeneic HCT\n3. Patients with scheduled 2nd allogeneic HCT within 12 months after 1st allogeneic HCT\n4. Pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization\n5. Planned TBI as part of conditioning\n6. Severe organ dysfunction defined by either one of the following criteria:\n\n   1. Serum bilirubin \\> 1.5 × ULN (if not considered Gilbert-syndrome) or\n   2. ALAT or ASAT \\> 5 × ULN\n7. Uncontrolled infection at the time of randomization.\n8. Active viral hepatitis unless serology demonstrates clearance of infection. Occult or prior hepatitis B virus (HBV) infection, defined as negative hepatitis B surface antigen and positive total hepatitis core antibodies, may be included if HBV DNA is undetectable, provided that patients are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody after vaccination or prior cured hepatitis B are eligible. Patients for hepatitis C virus (HCV) antibody are eligible provided PCR if negative for HCV RNA.\n9. Pregnant or breastfeeding women",{"count":150,"type":20},220,[152],"PHASE2","The aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation.\n\nThe following will also be investigated:\n\n* Survival\n* Remission and Relapse rate\n* Engraftment or graft failure\n* Graft versus Host Disease (GvHD)",[26,155],"MDS (Myelodysplastic Syndrome)","2025-09-02",{"date":158,"type":36},"2025-09-03",{"date":160,"type":20},"2025-09",{"date":162,"type":20},"2028-12",{"name":164,"class":140},"Technische Universität Dresden",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":44},"100569587","phase-2-gilteritinib-in-combination-with-venetoclax-and-azacitidine-for-aml-patients-with-flt3-mutations-ineligible-for-intensive-treatment-100569587","NCT06696183","Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment","Sequential Gilteritinib in Combination With Venetoclax and Azacitidine for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and FLT3 Mutations Ineligible for Intensive Treatment","SEQUENCE","Main Inclusion Criteria:\n\n* Newly diagnosed AML (according to WHO 2022 or ICC 2022 criteria) with a minimum BM blast count of \\>=20%, excluding APL\n* FLT3 mutation at initial diagnosis\n* Ineligibility of standard induction chemotherapy\n* Pre-treatment with approved combination of Venetoclax + Azacitidine (one cycle only)\n\nMain Exclusion Criteria:\n\n* R\u002FR AML\n* Previous treatment for AML (except HU and\u002For one cycle VEN+AZA according to SOC)\n* Previous treatment with Gilteritinib\n* Known active CNS involvement\n* QTcF \\>450 ms or long QT Syndrome at screening\n* Treatment with concomitant strong CYP3A inducers or St. John's wort",{"count":174,"type":20},60,[152],"Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy",[26],"2025-05-27",{"date":180,"type":36},"2025-05-29",{"date":182,"type":36},"2025-04-25",{"date":184,"type":20},"2030-04",{"name":164,"class":140}]