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

NARecruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

August 20, 2025

Primary Completion Date

August 20, 2027

Study Completion Date

August 20, 2028

Conditions
Acute Myeloid LeukemiaHigh-Risk Acute Myeloid LeukemiaMyelodysplastic SyndromesHigh-Risk Myelodysplastic Syndromes
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.

Trial Locations (1)

310006

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

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

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

collaborator

Ruijin Hospital North Shanghai Jiao Tong University School of Medicine

UNKNOWN

lead

First Affiliated Hospital of Zhejiang University

OTHER

NCT07183878 - Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study) | Biotech Hunter | Biotech Hunter