Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-Rearranged or NPM1-Mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: A Double-Blind Phase III Study

Objective

To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction and consolidation chemotherapy, followed by up to 24 cycles of maintenance therapy, prolongs EFS in adult participants with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy. EFS is defined as the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first. A participant has failed to achieve CR after remission induction if the participant s best response from the start of treatment until 42 days following the start of the last induction cycle is less than CR.