drugset / Trial / NCT05991908
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
RandomizedParallel-groupOpen-labelTreatment
Summary
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Timeline
- Start
- 2023-10-19
- Primary completion
- 2025-10-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Busulfan | Small molecule | 6.4 mg/kg | — |
| Comparator | Busulfan | Small molecule | 12.8 mg/kg | — |
| Subject | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | Fludarabine | Small molecule | 150 mg/m2 | — |