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NOT YET RECRUITING
NCT06133556
PHASE2

Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

Bu/Cy regimen

control group, the standard conditioning regimen Busulfan/Cyclophosphamide