This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
237
using MCBC as conditioning regimen, Mel 60mg/ m2 -9\~-8d, Cladribine 5 mg/m2 -9\~-5d, Bu3.2mg/kg -5\~-3d; Cy 30mg/kg -2\~-1 d
control group, the standard conditioning regimen Busulfan/Cyclophosphamide
Relapse Free Survival
The AML relapse free survival post-HSCT
Time frame: 3 year post-HSCT
Overall Survival
The overall survival post-HSCT
Time frame: 3 year post-HSCT
cumulative incidence relapse rate
cumulative incidence relapse rate post-HSCT
Time frame: 3 year post-HSCT
Non-relapse mortality
Non-relapse mortality post-HSCT
Time frame: 3 year post-HSCT
toxicity of conditioning regimen
Adverse events as assessed by CTCAE to evaluate conditioning related toxicity
Time frame: 24w post-HSCT
Immune reconstitution post-HSCT
Using lymphocyte subset panel to assess immune recovery post-HSCT
Time frame: 24w post-HSCT
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