drugset / Trial / NCT04713956
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Phase 2/3
Unknown
242 enrolled
Nanfang Hospital, Southern Medical University
First Affiliated Hospital of Guangxi Medical University · collabFirst People's Hospital of Chenzhou · collabGuangzhou First People's Hospital · collabInstitute of Hematology & Blood Diseases Hospital, China · collabPeking University People's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.
Timeline
- Start
- 2021-01-15
- Primary completion
- 2023-07-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Decitabine | Small molecule | 20 mg/m2 | — |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | — |