drugset / Trial / NCT06816134
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed/refractory AML or ALL patients aged ≤ 65 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The TmBU scheme or modified Bu/Cy (mBuCy) scheme was used for pretreatment in allo-HSCT. The primary endpoint of the study was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT, and the secondary endpoints were 2-year overall survival rate (OS), progressing-free survival rate (PFS), non-relapse mortality rate (NRM), graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) rate.
Timeline
- Start
- 2025-01-30
- Primary completion
- 2028-01-30
- Completion
- 2030-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | CDA | Unknown | 5 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 1.8 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2 g | — |
| Comparator | Lomustine | Small molecule | 250 mg/m2 | — |
| Subject | TmBU conditioning Regimen | Unknown | 7 mg/kg | — |
| Background | Cyclosporine | Peptide | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | rabbit anti-human antithymocyte globulin | Unknown | — | — |