The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The Number of Participants Experiencing Dose-limiting Toxicities (DLTs): Phase 1B (Dose Finding Stage)
Timeframe: From first dose to 28 days after first dose
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage)
Timeframe: From first dose to 28 days after last dose (up to approximately 13 months)
Overall Response Rate: Phase 2 (Randomized Stage)
Timeframe: From first dose up to approximately 26 months