[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607078":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":66,"collaborators":69,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":33,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vene-BUCY","EXPERIMENTAL","Participants in this arm will receive a venetoclax-enhanced BUCY conditioning regimen before undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Venetoclax is administered from day -14 to -8 (400 mg\u002Fday for patients ≥14 years; 360 mg\u002Fm²\u002Fday for patients aged 12-14 years). Standard BUCY regimen includes busulfan (0.8 mg\u002Fkg every 6 hours, days -7 to -4), cyclophosphamide (60 mg\u002Fkg\u002Fday, days -3 and -2), and MeCCNU (250 mg\u002Fm² on day -1). Antithymocyte globulin (ATG) may be added for donor or recipient age \\>40 years. Venetoclax dose is reduced if co-administered with strong CYP3A4 inhibitors such as posaconazole.",[13],"Drug: Venetoclax",{"label":15,"type":16,"description":17,"interventionNames":18},"BUCY","ACTIVE_COMPARATOR","Participants in this arm will receive the standard BUCY myeloablative conditioning regimen prior to allo-HSCT. The regimen includes busulfan (0.8 mg\u002Fkg every 6 hours, days -7 to -4), cyclophosphamide (60 mg\u002Fkg\u002Fday, days -3 and -2), and MeCCNU (250 mg\u002Fm² on day -1). ATG may be included in cases where the donor or recipient is over 40 years old. No venetoclax is used in this arm.",[19],"Other: None-placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Venetoclax","Venetoclax is administered orally at 400 mg\u002Fday for participants ≥14 years or 360 mg\u002Fm²\u002Fday for those aged 12-14 years, from day -14 to -8 before allogeneic hematopoietic stem cell transplantation (allo-HSCT). Dose is adjusted to 100 mg\u002Fday (or 90 mg\u002Fm²\u002Fday for pediatric patients) if used with strong CYP3A4 inhibitors such as posaconazole.",[9],[27,28],"ABT-199","Venclexta",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"None-placebo","Participants in this arm will not receive venetoclax as part of their conditioning regimen. They will undergo standard myeloablative conditioning with BUCY (busulfan, cyclophosphamide, and MeCCNU), prior to allogeneic hematopoietic stem cell transplantation. This arm serves as the active comparator to evaluate the addition of venetoclax in the experimental arm.",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Yanmin Zhao, MD","Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School Of Medicine","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":33,"email":43},"CONTACT","+8657187236706","yanminzhao@zju.edu.com",{"name":45,"role":41,"phone":33,"phoneExt":33,"email":46},"Zhao","wuhengwei@zju.edu.cn",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"The First Affiliated Hospital of Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310006","China","CN",{"type":57,"coordinates":58},"Point",[59,60],120.16142,30.29365,{"lat":60,"lon":59},[63],{"name":36,"role":41,"phone":64,"phoneExt":33,"email":65},"057187236706","yanminzhao@zju.edu.cn",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Yanmin Zhao","Dr",[70,72,74,76,78],{"name":71,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":73,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":75,"class":6},"Tongji Hospital",{"name":77,"class":6},"The Children's Hospital of Zhejiang University School of Medicine",{"name":79,"class":80},"Ruijin Hospital North Shanghai Jiao Tong University School of Medicine","UNKNOWN","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":93,"type":94},138,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100,101,102,103],"Acute Myeloid Leukemia","High-Risk Acute Myeloid Leukemia","Myelodysplastic Syndromes","High-Risk Myelodysplastic Syndromes",[23,105,106,107,108,109,110,111,112],"BUCY conditioning","Allogeneic Hematopoietic Stem Cell Transplantation","Myeloablative Conditioning","Relapse-Free Survival","Graft-versus-Leukemia","GVHD","High-Risk AML","High-Risk MDS","2025-09-14",{"date":115,"type":116},"2025-09-19","ACTUAL",{"date":118,"type":116},"2025-08-20",{"date":120,"type":94},"2028-08-20",{"name":5,"class":6},1]