drugset / Trial / NCT07085156
Reduced Intensity Conditioning for MDS
Phase 2
Not yet recruiting
45 enrolled
Ruijin Hospital
Wuhan Children's Hospital · collabWuhan TongJi Hospital · collabZhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only potential cure for Myelodysplastic syndrome (MDS). Currently, the conditioning regimen for MDS allogeneic transplantation still follows AML, and there are fewer explorations in this field. In a large-scale retrospective analysis with 532 MDS undergoing allo-HCT, reduced intensity conditioning is resulted in improved overall survival (OS), reduced non-relapse mortality (NRM) , while sparing relapse. Therefore, the investigators conduct a prospective, single-arm, multicentre study to evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan reduced-intensity conditioning in MDS patients.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2028-05-01
- Completion
- 2028-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Subject | Melphalan | Small molecule | 70 mg/m2 | — |