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.

This study is testing a combination of two drugs — ivosidenib and azacitidine — for people newly diagnosed with a specific type of blood cancer called AML (acute myeloid leukemia) that has a particular genetic mutation (IDH1) and who are not healthy enough for intensive chemotherapy. **You may be eligible if...** - You have newly diagnosed AML with an IDH1 R132 gene mutation - You are not able to receive intensive chemotherapy because you are 75 or older, have a poor performance status (ECOG 2), or have significant health problems (heart, lung, or kidney disease) - You have adequate liver and kidney function **You may NOT be eligible if...** - You have had any prior treatment for AML (other than hydroxyurea) - You have previously taken an IDH1 inhibitor - You are pregnant or breastfeeding - You have an uncontrolled serious infection (including HIV, active hepatitis B or C) - You have had a recent major heart event (heart attack, stroke, heart failure) within the past 6 months - You have difficulty swallowing or a condition that prevents you from absorbing oral medications Talk to your doctor to see if this trial is right for you.