The Dose Escalation portion of this study will identify the maximum tolerated dose, or if different, the recommended Phase 2 dose of revumenib to be used in combination with intensive chemotherapy and in maintenance monotherapy following intensive chemotherapy in participants with newly diagnosed AML harboring alterations in KMT2A, NPM1, or NUP98 genes.
In the Dose Expansion portion of the study, safety and preliminary efficacy of revumenib may be explored in expansion cohorts at tolerated dose levels.
In both Dose Escalation and Dose Expansion, the treatment period will consist of an induction phase (up to 2 cycles), a consolidation phase (up to 4 cycles and could include hematopoietic stem cell transplant for participants who are transplant eligible and have an available donor), and a maintenance monotherapy phase with revumenib. The cycle duration will be 28 days.
