Overview

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

Status:
RECRUITING

Trial end date:
2028-08-20

Target enrollment:

Participant gender:

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.

Phase:

Details

Lead Sponsor:

First Affiliated Hospital of Zhejiang University

Collaborators:

Ruijin Hospital North Shanghai Jiao Tong University School of Medicine
The Children's Hospital of Zhejiang University School of Medicine
The First Affiliated Hospital of Zhengzhou University
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Treatments:

venetoclax