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Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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.
Key Details
Gender
All
Age Range
Any - 60 Years
Study Type
INTERVENTIONAL
Enrollment
237
Start Date
2023-11-24
Completion Date
2028-10-20
Last Updated
2023-11-15
Healthy Volunteers
No
Conditions
Interventions
MCBC regimen
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
Bu/Cy regimen
control group, the standard conditioning regimen Busulfan/Cyclophosphamide