Clinical Trial

Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

Study acronym: BIG-1
Recruiting Phase 2/3
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Summary
This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2015-04-09; most recent amendment 2026-07-16.
Trial Details
NCT Number NCT02416388
Lead Sponsor University Hospital, Angers
Conditions Acute Myeloid Leukemia (AML)
Enrollment 3,100 participants
Start Date 2015-01
Primary Completion 2025-07-30 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17