Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Decitabine was administered at 20mg/m2/day on days -14 and -10.
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGrelapse rate
Time frame: 2 year
overall survival (OS)
Time frame: 2 year
disease-free survival (DFS)
Time frame: 2 year
transplant-related mortality (TRM)
Time frame: 2 year
Qifa Liu
CONTACT
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