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Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)

NCT07183878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-09-19

No results posted yet for this study

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 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

Interventions

DRUG

Venetoclax

Venetoclax is administered orally at 400 mg/day for participants ≥14 years or 360 mg/m²/day 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/day (or 90 mg/m²/day for pediatric patients) if used with strong CYP3A4 inhibitors such as posaconazole.

OTHER

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • Ruijin Hospital North Shanghai Jiao Tong University School of Medicine

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Yanmin Zhao, MD · Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School Of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2027-08-20
Completion
2028-08-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183878 on ClinicalTrials.gov