drugset / Trial / NCT02744742
G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Phase 2/3
Completed
202 enrolled
Nanfang Hospital, Southern Medical University
First People's Hospital of Chenzhou · collabInstitute of Hematology & Blood Diseases Hospital, China · collabLiuzhou Workers' Hospital · collabPeking University People's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study, the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are evaluated.
Timeline
- Start
- 2016-04-18
- Primary completion
- 2019-09-30
- Completion
- 2021-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Subject | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Background | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |