Revumenib in Patients With Myelofibrosis

This is a Phase Ib/II 2 study investigating the safety and efficacy of revumenib in two cohorts of participants with myelofibrosis. COHORT-1 will investigate the safety of revumenib as monotherapy in participants with myelofibrosis previously treated with a JAK inhibitor. Following confirmation of safety in COHORT-1, the study will proceed with enrollment in COHORT-2, which will evaluate the efficacy and safety of revumenib in combination with a JAK inhibitor. COHORT-2 will enroll participants on stable dose of a JAK inhibitor (ruxolitinib, fedratinib, or momelotinib) for at least 12 weeks at time of enrollment and who demonstrate suboptimal response as evidenced by persistent splenomegaly, symptoms or transfusion-dependent anemia, with revumenib added to existing JAK inhibitor therapy. The researchers hypothesize that revumenib will demonstrate a favorable safety profile in myelofibrosis participants, and demonstrate clinical activity (response of CR, PR or CI by IWG-MRT and ELN criteria) in participants with suboptimal response to a JAK inhibitor.