Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged

The purpose of this study is to evaluate an investigational drug called ziftomenib when added to either non-intensive chemotherapy (venetoclax and azacitidine) or intensive chemotherapy (cytarabine and daunorubicin), followed by ziftomenib maintenance therapy. Investigational means that ziftomenib has not been approved by the Food and Drug Administration (FDA) for use outside of research studies. Maintenance therapy refers to ongoing treatment given after the initial therapy to help keep the cancer from returning. Ziftomenib is being studied as a possible treatment for acute myeloid leukemia (AML), a type of blood cancer. In this study, participants may receive either the investigational drug or a placebo, which looks like the study drug but has no active ingredients. This helps researchers determine whether ziftomenib provides benefits beyond standard of treatment. The study will also examine side effects and explore why some patients may or may not respond to this treatment combination.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - Must not be diagnosis of either acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma