drugset / Trial / NCT06133556
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
RandomizedParallel-groupSingle-blindTreatment
Summary
This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
Timeline
- Start
- 2023-11-24
- Primary completion
- 2028-10-20
- Completion
- 2028-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 5 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 30 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 80 mg/kg | — |
| Subject | Mel | Unknown | 60 mg/m2 | — |
| Background | Busulfan | Small molecule | 3.2 mg/kg | — |