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.
Age ≥ 18 years and < 61 years
With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
No prior treatment for neither AML (with the exception of hydroxyurea), nor MDS (with the exception of EPO)
ECOG performance status ≤ 3
Patients enrolled in the BIG-1 trial at diagnosis
Patient presenting with AML in first CR or CRp/CRi after induction or one cycle of salvage therapy (confirmed in the 15 days preceding R4-VOS)
Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification
Patients randomized to R2-IDAC arm (intermediate dose cytarabine)
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Treatment groupsSee each treatment group below.