Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Status:
Recruiting
Trial end date:
2028-09-14
Target enrollment:
Participant gender:
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.