Actively Recruiting
Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-19
138
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) per 2022 WHO classification
- Age between 12 and 60 years
- High-risk MDS defined by IPSS intermediate-2/high risk or IPSS-R intermediate/high/very high risk, TP53 mutation, RAS pathway mutation, or therapy-related MDS
- High-risk AML defined by specific mutations, chromosomal abnormalities, complex or monosomal karyotype, high WBC count, secondary AML, or measurable residual disease positive before transplant
- For AML, must have achieved complete remission or remission with incomplete blood count recovery before transplant
- For MDS, bone marrow blasts less than 20%
- Availability of a matched related or unrelated donor with 9/10 or 10/10 HLA match
- ECOG performance status of 0 to 2
- Creatinine clearance at least 60 mL/min
- Liver enzymes AST/ALT no more than 3 times the upper limit of normal and total bilirubin no more than 2 times the upper limit of normal
- Left ventricular ejection fraction at least 50% by echocardiogram
- Life expectancy greater than 8 weeks
- Willingness to use effective contraception during and after the study
- Signed informed consent
You will not qualify if you...
- Uncontrolled cardiovascular disease or New York Heart Association class III or IV heart failure
- Severe other medical 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 or higher non-hematologic adverse reaction to prior venetoclax therapy
- Receipt of chemotherapy (except hydroxyurea or dexamethasone) or radiotherapy within 14 days before study treatment
- Ongoing use of BCR-ABL1, IDH, or FLT3 inhibitors without proper washout period of at least 7 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
Y
Yanmin Zhao, MD
CONTACT
Z
Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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