drugset / Trial / NCT06829472
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Phase 3
Recruiting
120 enrolled
Shanghai Jiao Tong University School of Medicine
Shanghai Clinical Research Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
Timeline
- Start
- 2023-12-01
- Primary completion
- 2026-07-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 100 mg/m2 | — |
| Subject | Melphalan | Small molecule | 140 mg/m2 | — |