Status: Recruiting
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.
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \[IDH1m\]) and cannot receive treatment with intensive chemotherapy (IC).
Participants needed: 245
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Servier Affaires MédicalesUpdated: May 8, 2026Locations: 15
Eligibility criteria
Has untreated Acute Myeloid Leukemia (AML) [+5]
Has received any prior treatment for AML, with the exception of hydroxyurea or l... [+6]