drugset / Trial / NCT02744742

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

EvaluationDrugModalityDoseRoute
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