[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-myelodysplastic-syndromes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-myelodysplastic-syndromes":54},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100607078","venetoclax-enhanced-bucy-vs-standard-bucy-conditioning-in-high-risk-aml-and-mds-patients-undergoing-allo-hsct-ven-bucy-study-100607078",false,"NCT07183878","Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)","A Prospective, Multicenter, Randomized Controlled Study Comparing Venetoclax-Enhanced BUCY With Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Ven-BUCY","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to 2022 WHO classification\n* Age between 12 and 60 years\n* High-risk MDS as defined by at least one of the following:\n\n  * IPSS intermediate-2\u002Fhigh risk or IPSS-R intermediate\u002Fhigh\u002Fvery high risk\n  * TP53 mutation\n  * RAS pathway mutation (e.g., NRAS, KRAS, PTPN11, CBL, NF1, RIT1, FLT3, KIT)\n  * Therapy-related MDS\n* High-risk AML as defined by at least one of the following:\n\n  * TP53, RUNX1, or ASXL1 mutation\n  * t(6;9)(p23;q34.1)\u002FDEK-NUP214\n  * KMT2A rearrangement\n  * BCR-ABL1 fusion\n  * inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\n  * -5\u002Fdel(5q), -7, -17\u002Fabn(17p)\n  * Complex or monosomal karyotype\n  * FLT3-ITD high with wild-type NPM1\n  * Initial WBC ≥ 10×10\\^9\u002FL\n  * Secondary AML with history of MDS\u002FMPN or therapy-related AML\n  * AML with specific mutations (SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, STAG2)\n  * MRD positive before transplantation\n* For AML: must have achieved CR or CRi prior to transplantation; for MDS: bone marrow blasts \\\u003C 20%\n* Availability of a matched related or unrelated donor (10\u002F10 or 9\u002F10 HLA match)\n* ECOG performance status 0-2\n* Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault)\n* AST\u002FALT ≤ 3 × ULN and total bilirubin ≤ 2 × ULN\n* LVEF ≥ 50% by echocardiogram\n* Life expectancy \\> 8 weeks\n* Willingness to use effective contraception methods during and for a specified period after the study\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled cardiovascular disease or New York Heart Association class III\u002FIV heart failure\n* Other severe comorbid conditions that may interfere with study participation\n* Known HIV infection or uncontrolled active hepatitis B or C\n* Pregnant or breastfeeding women\n* More than one prior hematopoietic stem cell transplantation\n* Inability to understand the study protocol or provide informed consent\n* History of grade ≥ 3 non-hematologic adverse reaction to prior venetoclax therapy\n* Receipt of chemotherapy (except hydroxyurea\u002Fdexamethasone) or radiotherapy within 14 days before study treatment\n* Ongoing use of BCR-ABL1, IDH, or FLT3 inhibitors without proper washout (≥ 7 days)","ALL","12 Years","60 Years",{"count":21,"type":22},138,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy and safety of venetoclax-enhanced BUCY (Ven-BUCY) conditioning compared to the standard BUCY regimen in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants aged 12 to 60 years will be randomized 1:1 to receive either Ven-BUCY or standard BUCY conditioning. The primary endpoint is relapse-free survival (RFS) at two years post-transplant. Secondary outcomes include overall survival, relapse rate, non-relapse mortality, measurable residual disease (MRD), and treatment-related adverse events. The study aims to improve post-transplant outcomes by deepening disease remission through the addition of venetoclax, a BCL-2 inhibitor known to target leukemia stem cells and enhance chemotherapy sensitivity.",[28,29,30,31],"Acute Myeloid Leukemia","High-Risk Acute Myeloid Leukemia","Myelodysplastic Syndromes","High-Risk Myelodysplastic Syndromes",[33,34,35,36,37,38,39,40,41],"Venetoclax","BUCY conditioning","Allogeneic Hematopoietic Stem Cell Transplantation","Myeloablative Conditioning","Relapse-Free Survival","Graft-versus-Leukemia","GVHD","High-Risk AML","High-Risk MDS","RECRUITING","2025-09-14",{"date":45,"type":46},"2025-09-19","ACTUAL",{"date":48,"type":46},"2025-08-20",{"date":50,"type":22},"2028-08-20",{"name":52,"class":53},"First Affiliated Hospital of Zhejiang University","OTHER","High-risk Myelodysplastic Syndromes"]