Outcome for acute myeloid leukemia (AML) patients aged >60 years is poor. Targeting the proteasome in AML is attractive, since leukemia stem cells demonstrate sensitivity to proteasome inhibition in preclinical models. Adults >60 years of age with newly diagnosed AML were enrolled. Induction consisted of cytarabine and daunorubicin with ixazomib provided on days 2, 5, 9, and 12. In a second phase, induction was followed by consolidation with cytarabine and ixazomib on days 2, 5, 9, and 12. Among the 39 patients enrolled, there was 1 DLT, grade 4 thrombocytopenia. There were no grade 3 or 4 neurotoxicity events attributable to ixazomib. The composite remission rate (CCR) was 69%. The median OS for the 39 patients was 38.5 months. The highest dose level (3 mg) of ixazomib planned for induction and consolidation in this trial has been reached safely and is the RP2D for both.
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