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Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Sponsor: Nantes University Hospital
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
Conditions
Interventions
Fludarabine
30 mg/m2/day IV fludarabine for 5 days (day-6 to day-2)
Busulfan
130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)
ATG
Thymoglobuline®: 2.5 mg/Kg/day IV for 2 consecutive days (day -2 and -1)
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