Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial Primary Objective The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT. Secondary Objective The secondary objective of this study is to compare leukemia relapse, engraftment, GVHD, OS, TRM, AEs and RRT between Sel2Mel2BU2FLU3 and BU3FLU5 groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Hebei Medical University Second Hospital
Shijiazhuang, Hebeisheng, China
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China
1-year RFS
The primary objective of this study is to compared 1-year RFS between Sel2Mel2BU2FLU3 and BU3FLU5 groups for elder AML in CRc undergoing allo-HCT.
Time frame: 1-year
1-year OS
1-year OS
Time frame: 1-year
1-year GVHD
1-year GVHD
Time frame: 1-year
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30 mg/m² on days