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

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 ove

Trial Details

NCT ID
NCT07183878
Phase
NA
Sponsor
First Affiliated Hospital of Zhejiang University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax
  • None-placebo
  • Busulfan (BU)
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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