Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years' old * De novo or secondary AML (according to ELN 2022 classification) in complete cytological remission at time of transplant (bone marrow blast count \< 5%) or MDS/LAM with bone marrow blast count ≤ 5% * Patients in first or second line therapy are allowed * Patient eligible to a RIC regimen : patients aged ≥ 60 year old or \<60 with co-morbidity(ies). * Patient with a related or an unrelated matched donor * Graft using only peripheral blood stem cells * Performance status ECOG 0 - 2 * Who provide their written informed consent * Previous allograft allowed * Affiliated with French social security system or beneficiary from such system * Women must meet one of the following criteria at the time of inclusion: * use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1; includes injectable implants, dual hormone birth control pills, intrauterine devices, abstin