At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
In Brief
A Phase 3 clinical trial evaluating Granulocyte Colony-Stimulating Factor(G-CSF), Decitabine (DAC), and 3 other interventions for Myelodysplastic Syndrome and 2 related conditions. Targeting 242 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.