NCT05917405

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2023-09-14
• Primary completion: 2028-09-14
• Completion: 2028-09-14
• First posted: 2023-06-23
• Last updated: 2026-01-30

Locations

23 sites across 1 country: France