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Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

NCT06133556 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2028-10-20
Completion
2028-10-20

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133556 on ClinicalTrials.gov