Clinical Trial

A Prospective Single-Arm Study of VABu Conditioning Regimen in Allo-HSCT for Low-Performance or High-Comorbidity AML Patients in CR1

Study acronym: VABu
Not Yet Recruiting
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Summary
This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.
Trial Details
NCT Number NCT07762508
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Leukemia, Myeloid, Acute(AML), Hematopoietic Stem Cell Transplantation (HSCT)
Enrollment 42 participants
Start Date 2026-08
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13