[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypomethylating-agent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypomethylating-agent":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100503938","phase-2-hypomethylating-agent-and-venetoclax-after-allo-hsct-in-patients-with-high-risk-myeloid-malignancies-100503938",false,"NCT05841771","Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.","A Single Arm, Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With f High-risk Myeloid Malignancies.","Inclusion Criteria:\n\n* Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation;\n* Patients with AML must have one of the following high-risk factors: Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML； require more than 2 courses of induction chemotherapy to reach complete remission； Extramedullary myeloid malignancy；≥CR2； Presence of measurable residual disease at the time of HSCT. \\*\n* Patients with MDS must have one of the following high-risk factors: IPSS-R scores are high-risk or very high-risk； Presence of TP53 mutation； Presence of measurable residual disease at the time of HSCT. \\*\n* CBC: ANC ≥ 1.0 × 10e9\u002FL, Hb ≥ 80g\u002FL, and PLT ≥ 50 × 10e9\u002FL；\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\n  * Presence of measurable residual disease at the time of HSCT is defined as the following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%； Presence of fusion gene or mutated gene by qPCR.\n\nExclusion Criteria:\n\n* Concurrent use of targeted drugs ;\n* Resistant to Venetoclax before transplantation;\n* Allergic to decitabine , Azacitidine or venetoclax;\n* Active grade II or higher acute GVHD ;\n* Active moderate or severe chronic GVHD ;\n* Diseases recurrence (abnormal myeloid cells detected by flow cytometry \\>0.01%, presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \\\u003C90% or graft rejection:\n* CBC: ANC \\\u003C 1.0 × 10e9\u002FL, or PLT \\\u003C 50 × 10e9\u002FL；\n* Severe organ dysfunction: Elevated Aspartate transaminase (AST) \u002Falanine transaminase (ALT), or direct bilirubin \\>3 times upper limit of normal; Creatinine clearance (Ccr)\\\u003C50mL\u002Fmin or serum creatinine \\>1.5 times upper limit of normal, whether hemodialysis treatment is performed;\n* Active uncontrolled systemic fungal, bacterial, or viral infection\n* Pregnant or lactating women;\n* Other severe complications and not suitable judged by researchers.","ALL","18 Years","70 Years",{"count":20,"type":21},78,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .",[27,28,29],"Hypomethylating Agent","Venetoclax","Myeloid Malignancy","RECRUITING","2024-08-08",{"date":33,"type":34},"2024-08-09","ACTUAL",{"date":36,"type":34},"2023-01-01",{"date":38,"type":21},"2025-12-31",{"name":40,"class":41},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER"]