According to the 2022 ELN guidelines patients with high-risk acute myeloid leukemia were randomly divided into MA-BUCY2 conditioning group and BuCy2 conditioning group,to evaluate the efficacy and safety of two conditioning regimens in haploidentical hematopoietic stem cell transplantation.
High risk acute myeloid leukemia patients were randomly divided into two groups before conditioning of haploidentical hematopoietic stem cell transplantation.The control group will use the BUCY2 conditioning,and the experimental group will use mitoxantrone liposome combined with BUCY2 for conditioning. After transplantation,we will observe the difference of one year relapse rates between two goups,also the adverse reactions of conditioning,GVHD,OS and PFS of the patients in two groups also been observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Mitoxantrone liposome 20mg/m2,ivgtt,d-11 ;Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2
Ara-C 4g/m2.d ,ivgtt,d-10- -9; BU 0.8 mg/kg q6h,ivgtt,d-8- -6; CTX 1.8 g/m2.d ,ivgtt,d-5- -4; me-CCNU 250 mg/m2,p.o,d-3; ATG 2.5 mg/Kg.d,d-5 -2
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
relapse rates
blast cells in bone marrow are greater than or equal to 5%. Blast cells can be seen in peripheral blood or extramedullary relapse occurred.
Time frame: one year after transplantation
AEs
adverse reactions of conditioning regimen include nausea, vomiting, abdominal pain, diarrhea, heart, liver and kidney toxicity
Time frame: from beginning of the conditioning to one month after conditioning
aGVHD
the incidence of acute graft versus host disease
Time frame: At day 100 post-transplantation
OS
overall survival
Time frame: From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.
PFS
progression free survival
Time frame: From date of HSCT until the end of follow-up or the date of disease relapse from any cause, whichever came first,assessed up to 36 months.
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