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Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

NCT05917405 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2026-01-30

No results posted yet for this study

Summary

Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.

Conditions

  • Acute Myeloid Leukemia in Remission

Interventions

DRUG

Fludarabine

30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)

DRUG

Busulfan

130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)

DRUG

ATG

Thymoglobuline®: 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)

DRUG

Clofarabine

30 mg/m2/day IV clofarabine for 5 days (day-6 to day-2)

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • patrice CHEVALLIER, Pr · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2028-09-14
Completion
2028-09-14

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT05917405 on ClinicalTrials.gov