Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.
In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.
Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole.
Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.
Arm C: Participants receiving revumenib in combination with cobicistat.
Arm D: Participants receiving fluconazole (moderate CYP3A4 inhibitor).
Diagnosis of active acute promyelocytic leukemia.
Isolated extramedullary relapse (Phase 2 Cohorts 2A-2C only).
Active central nervous system disease (cytologic, such as any blasts on cytospin, or radiographic).
Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Participants with a known history of HIV 1/2 antibodies must have viral load testing prior to study enrollment.
Syndax Pharmaceuticals
Lead sponsor