MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia

Patients with refractory or relapsed acute myeloid leukemia (R/R AML) possess a poor prognosis, having a high unmet medical need. Idasanutlin is really a small-molecule inhibitor of MDM2, an adverse regulator of tumor suppressor p53. By stopping the p53-MDM2 interaction, idasanutlin enables fo rRG-7388 p53 activation, specifically in patients with TP53 wild-type (WT) status. MIRROS (NCT02545283) is really a randomized Phase III trial evaluating idasanutlin cytarabine versus placebo cytarabine in R/R AML. The main finish point is overall survival within the TP53-WT population. Secondary finish points include complete remission rate (cycle 1), overall remission rate (cycle 1) and event-free survival within the TP53-WT population. MIRROS comes with an innovative design that integrates a stringent interim analysis for futility continuation criteria were met in mid-2017 and accrual is ongoing