Allo-HSCT is the most effective way to cure sAML patients. At present, the best conditioning regimen for sAML patients 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 sAML patients undergoing allo-HSCT are evaluated.
Allo-HSCT is the most effective way to cure secondary acute myeloid leukemia evolving from MDS (sAML) patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+ BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
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 .
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGNon-relapse mortality (NRM)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Disease-free survival (DFS)
Time frame: 1 year
Cumulative incidence of relapse
Time frame: 1 year
Adverse effects
Time frame: within 100 days post-transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.