Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. In this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in CR1, but the choice between BU-based or TBI-based conditioning regimen still remains controversial.In order to analyze the impact of conditioning regimen on long-term survival and relapse, in this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
550
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.
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
overall survival (OS)
Time frame: 2 year
leukemia relapse rate
Time frame: 2 year
disease-free survival (DFS)
Time frame: 2 year
transplant-related mortality (TRM)
Time frame: 2 year
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