A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Exclusion Criteria

• •Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy. Patients who have stopped calcineurin inhibitors (CNI) must be off CNIs for at least 2 weeks prior to day 1 of protocol therapy
• •Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy with the following exception of hydroxyurea which is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia
• •Strong inducers or strong inhibitors of CYP enzymes (e.g., 1A2, 2B6, 2C8, 2C9, 2C19, and 3A4), other than azole antifungals with CYP3A4 inhibition potential, or drug transporters (e.g., organic anions \[OATP1B1/1B3\], BCRP, P-gp, organic cations \[OCT1, OCT2, OCT3\], MATE1 or MATE2K), or sensitive substrates of these CYPs or drug transporters, within 4-5 half-lives or 14 days prior to the first dose of study drug, whichever is longer.
• •Foods/supplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment
• •Systemic steroid therapy \> 10 mg/day (≤ 10mg/day prednisone equivalent ok) or any other form of immunosuppressive medication within 14 days. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted
• •Must not have received or planning to receive live vaccine while being on study or 4 weeks before and after completion of treatment
• •Patients with blast phase chronic myeloid leukemia (CML)
• •Patients with translocation (t)(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML)
• •Active central nervous system (CNS) disease
• •Active graft versus (vs) host disease (GVHD)
• •Unstable cardiac disease as defined by one of the following:
• •* Cardiac events such as myocardial infarction (MI) within the past 6 months
• •* Uncontrolled atrial fibrillation or hypertension
• •No measurable disease in the bone marrow
• •Gastrointestinal disorder that interferes with oral drug absorption such as malabsorption syndrome
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
• •Uncontrolled active infection
• •Clinically significant uncontrolled illness
• •Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• •Females only: Pregnant or breastfeeding
• •Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)