Expanded Access to Ziftomenib

For people ages 18 years and up

Inclusion/Exclusion Criteria:

• Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
• Adult, ages 18+.
• Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).
• Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.
• Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.