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RECRUITING
NCT05917405
PHASE2

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Official title: FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2023-09-14

Completion Date

2028-09-14

Last Updated

2026-01-30

Healthy Volunteers

No

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)

Locations (23)

CHU de Nantes

Nantes, Loire Atlantique, France

CHU Amiens

Amiens, France

CHU Angers

Angers, France

CHU Besançon

Besançon, France

CHU Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CRLC Caen

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

APHP Créteil

Créteil, France

CHU Grenoble

Grenoble, France

CHRU Lille

Lille, France

CHU Limoges

Limoges, France

CHU Lyon

Lyon, France

Institut Paoli Calmettes

Marseille, France

CHU Montpellier

Montpellier, France

CHRU Nancy

Nancy, France

CHU Paris St-Louis

Paris, France

Pitie-Salpetriere, APHP

Paris, France

St-Antoine, APHP

Paris, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

CHU St-Etienne

Saint-Etienne, France

CRLC Toulouse

Toulouse, France