VABu Conditioning in Elderly AML HSCT
This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The VABu regimen consists of Venetoclax, Azacitidine,
| Condition(s) | Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Acute Myeloid Leukemia (AML) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT. The study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytom |
| Who can participate | Inclusion Criteria: 1. Age ≥ 60 years. 2. Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis. 3. Previous response to Venetoclax-based therapy. 4. Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT). 5. Donor availability: Related donor matched at least 5/10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8/10 at the same loci. 6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4. 7. ECOG performance status 0-2. 8. Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL/min (Cockcroft-Gault formula or 24-hour urine collection)； AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN； Total bilirubin ≤ 1.5 × ULN； Left ve |
| Ages | 60 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2026-05-07 |
| NCT ID | NCT07583888 |
| Official listing | https://clinicaltrials.gov/study/NCT07583888 |