A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

Inclusion Criteria: * Voluntary written informed consent and willingness to comply with all study procedures * Age ≥ 18 years * Confirmed diagnosis of acute myeloid leukemia (AML) * Patients with R/R AML with NPM1-m * No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy. * ECOG performance status 0-2. * White blood cell count ≤ 30,000/mm³ at screening (hydroxyurea permitted for cytoreduction). * Adequate organ function according to protocol requirements. * Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment. * Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia. * Donor lymphocyte infusion \< 30 days prior to study entry. * Clinically active central nervous system (CNS) leukemia. * Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery. * Active Grade ≥ 2 acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease. * Prior treatment with a menin inhibitor. * Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose. * Unresolved toxicities from prior therapy \> Grade 1. * Requirement for strong CYP3A4 inducers. * Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV. * Conditions predisposing to serious or life-threatening infection or significant immunodeficiency. * Cardiovascular disease or QTcF \> 480 ms. * Interstitial lung disease. * Major surgery within 4 weeks prior to first dose. * Women who are pregnant or lactating * Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.