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

Study acronym: FLUCLORIC
StatusRecruiting
PhasePhase 2
Started2023-09-14
View on ClinicalTrials.gov ↗

Amendment history

2026-01-28
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Eligibility criteria+47 characters
[...] mission 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 Patien [...] Hepatitis B or C Left ventricular ejection fraction < 50%. DLCODLCOc <40% Uncontrolled infection Uncontrolled haemolytic anaemia [...] < 50 ml/min (evaluated by MDRD or CKDEPI). Serum bilirubine <> 30 mmol/l, Cytolysis > 5 the upper limit range Previous or [...]
Secondary endpointsdetails revised at 2 of 23 entries
Study sitesdetails revised at 13 of 23 sites
2023-11-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-07-01→2028-09-14
Completion date2028-07-01→2028-09-14
Start dateestimated 2023-07-01→confirmed 2023-09-14
Study sitesdetails revised at 23 of 23 sites
2023-06-15
Original filing
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.
Trial Details
NCT Number NCT05917405
Lead Sponsor Nantes University Hospital
Conditions Acute Myeloid Leukemia in Remission
Enrollment 302 participants
Start Date 2023-09-14
Primary Completion 2028-09-14 (estimated)
Study Completion 2028-09-14 (estimated)
Updated on ClinicalTrials.gov 2026-01-30