Status:
RECRUITING
Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Acute Myeloid Leukemia
High-Risk Acute Myeloid Leukemia
Eligibility:
All Genders
12-60 years
Phase:
NA
Brief Summary
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 i...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). However, post-transplan...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to 2022 WHO classification
- Age between 12 and 60 years
- High-risk MDS as defined by at least one of the following:
- IPSS intermediate-2/high risk or IPSS-R intermediate/high/very high risk
- TP53 mutation
- RAS pathway mutation (e.g., NRAS, KRAS, PTPN11, CBL, NF1, RIT1, FLT3, KIT)
- Therapy-related MDS
- High-risk AML as defined by at least one of the following:
- TP53, RUNX1, or ASXL1 mutation
- t(6;9)(p23;q34.1)/DEK-NUP214
- KMT2A rearrangement
- BCR-ABL1 fusion
- inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)
- -5/del(5q), -7, -17/abn(17p)
- Complex or monosomal karyotype
- FLT3-ITD high with wild-type NPM1
- Initial WBC ≥ 10×10\^9/L
- Secondary AML with history of MDS/MPN or therapy-related AML
- AML with specific mutations (SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, STAG2)
- MRD positive before transplantation
- For AML: must have achieved CR or CRi prior to transplantation; for MDS: bone marrow blasts \< 20%
- Availability of a matched related or unrelated donor (10/10 or 9/10 HLA match)
- ECOG performance status 0-2
- Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
- AST/ALT ≤ 3 × ULN and total bilirubin ≤ 2 × ULN
- LVEF ≥ 50% by echocardiogram
- Life expectancy \> 8 weeks
- Willingness to use effective contraception methods during and for a specified period after the study
- Signed informed consent
Exclusion
- Uncontrolled cardiovascular disease or New York Heart Association class III/IV heart failure
- Other severe comorbid conditions that may interfere with study participation
- Known HIV infection or uncontrolled active hepatitis B or C
- Pregnant or breastfeeding women
- More than one prior hematopoietic stem cell transplantation
- Inability to understand the study protocol or provide informed consent
- History of grade ≥ 3 non-hematologic adverse reaction to prior venetoclax therapy
- Receipt of chemotherapy (except hydroxyurea/dexamethasone) or radiotherapy within 14 days before study treatment
- Ongoing use of BCR-ABL1, IDH, or FLT3 inhibitors without proper washout (≥ 7 days)
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2028
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07183878
Start Date
August 20 2025
End Date
August 20 2028
Last Update
September 19 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006