MM1OA-S03: Acute Myeloid Leukemia

If you choose to join this study, you will take part in either Part 1 or Part 2. Whether you participate in Part 1 or Part 2 will depend on when you join the study. If you participate in Part 1 of the study, you will take a regimen of the study drug, venetoclax, and enasidenib. We will monitor everyone who takes part in Part 1 for side effects, and if the combination does not cause any serious or unanticipated side effects, the study will proceed to Part 2. If you participate in Part 2 of the study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

• Group 1: If you are in this group, you will get the study drug and venetoclax. Both drugs are taken by mouth. You will take the study drug on a schedule that corresponds to a 28-day period called a "cycle." On Days 1-5 of each cycle, you will take the study drug once a day. You will also take venetoclax once a day for 21 to 28 days based on how your AML responds. During your first cycle, you will start with lower doses of venetoclax on Days 1 and 2. You will take the full dose starting on Day 3. In later cycles, the number of days of taking the study drug and venetoclax may be adjusted to limit side effects. After 2 cycles, we will test your bone marrow to see how well you are responding to the regimen. You will continue on this regimen for as long as you are receiving a positive benefit.
• Group 2: If you are in this group, you will get the study drug, venetoclax, and enasidenib as pills you take by mouth for each cycle. One cycle is 28 days. On Days 1-5 of each cycle, you will take the study drug once a day. You will take venetoclax once a day for 21 to 28 days based on how your AML responds. During your first cycle, you will start with lower doses of venetoclax on Days 1 and 2. You will take the full dose starting on Day 3. You will take enasidenib once a day for every day of each cycle. After 2 cycles, we will test your bone marrow to see how well you are responding to the regimen. You will continue on this regimen for as long as you are receiving a positive benefit.