Study assessments
ADVERSE EVENT, ADVERSE EVENT
The primary objectives of the phase 1 portion of this study were to assess safety, the MTD or, if different, RP2D and to characterize the pharmacokinetic parameters of revumenib in arms based on concomitant CYP3A inhibitors. Exploratory objectives included assessment of antileukaemic activity in the efficacy population, which consisted of patients with Adverse events were graded with use of the Common Terminology Criteria for Adverse Events, v.5.0. Clinical efficacy was assessed by the investigators with use of a modified version of the 2017 European LeukemiaNet response criteria, to additionally include CRh