[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allogeneic-hematopoietic-cell-transplantation-hct\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allogeneic-hematopoietic-cell-transplantation-hct":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100628593","phase-3-mrd-guided-maintenance-post-hct-gilteritini-vs-sorafenib-100628593",false,"NCT07463651","MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib","Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients","TROPHY-15","Inclusion Criteria:\n\n* Informed consent and willingness to participate in this clinical study;\n\n  * Gender is not limited, age range is 14-70 years old (including threshold);\n\n    * ECOG score 0-2 points;\n\n      * Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;\n\n        * Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source \\[fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood\\], allowing any graft source \\[umbilical cord blood, bone marrow (BM), peripheral blood (PB)\\]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6);\n\n          ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500\u002Fμ L, platelet count ≥ 20000\u002Fμ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose\\>0.5 mg\u002Fkg, acute GVHD;\n\n          ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg\u002FdL (excluding Gilbert syndrome patients); c. Serum AST and\u002For ALT\\\u003C3 times the upper limit of normal values;\n\n          ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;\n\n          ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;\n\nExclusion Criteria:\n\n* Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;\n\n  * Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;\n\n    * FLT3-ITD molecular MRD positivity before maintenance therapy;\n\n      * Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;\n\n        * Subjects who are positive for hepatitis B B surface antigen (HBsAg) and whose hepatitis B virus (HBV) DNA titer is higher than the upper limit of the normal value range of the research center, and who are judged by the researchers not suitable for this study; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; Individuals who are HIV antibody positive; Positive syphilis test results;\n\n          ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;\n\n          ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;\n\n          ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;\n\n          ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;\n\n          ⑩ Researchers have determined that individuals are not suitable to participate in this clinical trial.","ALL","14 Years","70 Years",{"count":21,"type":22},594,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.\n\nAll patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.\n\nStudy Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.",[28,29,30,31,32,33],"Acute Myeloid Leukemia (AML)","FLT3-ITD Mutation","Allogeneic Hematopoietic Cell Transplantation (HCT)","Maintenance Therapy","Gilteritinib","Sorafenib",[35,29,36,37,32,38],"Acute Myeloid Leukemia","Allogeneic Hematopoietic Cell Transplantatio","Maintenance therapy","sorafeni","RECRUITING","2026-03-18",{"date":42,"type":43},"2026-03-20","ACTUAL",{"date":45,"type":22},"2026-05-01",{"date":47,"type":22},"2030-03-31",{"name":49,"class":50},"The First Affiliated Hospital of Soochow University","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100616332","phase-2-post-transplantation-maintenance-therapy-with-cidabenamide-in-patients-with-intermediatehigh-risk-aml-100616332","NCT07304232","Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate\u002FHigh-risk AML","Multicentre, Phase II Clinical Study of Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate\u002FHigh-risk AML","CM-AML-001","Inclusion Criteria:\n\n1. AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-\u002Fhigh-risk cytogenetic abnormalities at the time of allogeneic transplantation.\n2. Patients must achieve complete remission (CR) post-transplantation.\n3. Enrollment must occur between 60 and 100 days after transplantation.\n4. Age 18 to 75 years.\n5. ECOG performance status 0-1.\n6. Serum creatinine \\\u003C 1.5 × ULN (upper limit of normal).\n7. Serum direct bilirubin \\\u003C 1.5 mg\u002FdL (except in Gilbert's syndrome).\n8. ALT and AST \\\u003C 2.5 × ULN.\n9. Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n1. Receipt of any other investigational drugs post-transplantation.\n2. FLT3 mutation-positive status.\n3. Central nervous system (CNS) involvement.\n4. Uncontrolled grade 2-4 graft-versus-host disease (GVHD).\n5. Uncontrolled active infection.\n6. Known or suspected hypersensitivity to Chidamide or its excipients.\n7. Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen.\n8. Pregnancy or breastfeeding.\n9. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.","18 Years","75 Years",{"count":62,"type":22},134,[64],"PHASE2","This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation.\n\nTrial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determined by the treating physician. Patients had received induction and\u002For consolidation therapy, achieved remission, and underwent stem cell transplantation.\n\nStudy Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).",[30,67],"AML (Acute Myeloid Leukemia)","2025-12-11",{"date":70,"type":43},"2025-12-26",{"date":72,"type":43},"2025-09-01",{"date":74,"type":22},"2028-12-31",{"name":76,"class":50},"Institute of Hematology & Blood Diseases Hospital, China",5]