Open-label Phase 3b Study of Ivosidenib with Azacitidine in Adults Newly Diagnosed with IDH1-mutated Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy

What this Trial Is About

Researchers are studying the safety and effects of using ivosidenib combined with azacitidine to treat adults who have newly diagnosed acute myeloid leukemia (AML) with a specific IDH1 gene mutation, and who cannot undergo intensive chemotherapy. This open-label Phase 3b study focuses on evaluating how these treatments work together in this particular patient group, aiming to provide important information about their tolerability and outcomes. In this study, all participants will receive both ivosidenib and azacitidine for up to 28 treatment cycles, each lasting 28 days. Ivosidenib is taken daily throughout each cycle as two 250mg oral tablets, while azacitidine is given either under the skin or through a vein for 7 days at the start of each cycle. If ivosidenib becomes available as a prescription drug locally, patients may switch to the commercial product but will continue to be followed by the study protocol. Participants will have a study visit on the first day of each 28-day cycle, including physical exams, blood tests, electrocardiograms, and other assessments. After stopping treatment, they will be contacted every 12 weeks to check survival status until the study ends. Researchers will monitor adverse events, response rates, quality of life, and other health outcomes up to about 116 weeks to understand treatment safety and effects.

An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.