FILO-AML-01-MIVONU A single arm phase II study investigating the efficacy and safety of the addition of ivosidenib to oral azacitidine (Onureg®) in patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy. A study of the French AML Intergroup.

Condition studied

Patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.

Endpoint detail

RFS at 12 months, with the same definition for RFS as for the primary endpoint., Overall survival defined as the time between inclusion assignment and death from any cause, at 12 and 24 months. Patients alive will be censored at the date of last news, or data cutoff., EFS MRD-, defined in patients who were MRD negative at baseline as the time from inclusion to MRD relapse (by FCM or RT-qPC for NPM1) or death from any cause, whichever occurred first. Patients alive without MRD relapse will be censored at the date of last MRD assessment., Number of participants with Treatment Emergent Adverse Events (TEAEs), according the CTCAE v5.0 classification.