New targeted therapy shows promise for Tough-to-Treat leukemia

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * To be considered eligible for enrollment into this study, all of the following inclusion criteria must be met during the screening period: * Documented AML by peripheral blood and bone marrow analyses meeting WHO criteria, excluding patients with acute promyelocytic leukemia (APL) * Patients with AML refractory to primary induction chemotherapy, relapsed disease, or age ≥ 60 and not appropriate for standard cytotoxic therapy due to age, performance status, and/or adverse risk factors according to the treating physician * Age ≥ 18 years * Karnofsky performance status ≥ 50% or ECOG performance status 0-2 * Life expectancy ≥ 6 weeks * Able to understand the investigational nature of this study and to provide written consent to participate in it * Signed written IRB-approved Informed Consent document * Adequate hepatic and renal function: * serum bilirubin ≤ 1.5 X institutional ULN OR serum direct bilirubin ≤ 2 X institutional ULN * serum ALT and AST ≤ 2.5 X institutional ULN * serum alkaline phosphatase \< 5 X institutional ULN * serum creatinine ≤ 2.0 mg/dL * corrected calcium level ≥ institutional LLN * Negative pregnancy test in women of child-bearing potential * Women and men of child-producing potential must agree to use effective contraceptive methods during the study period (including post-treatment observation period) Exclusion Criteria: * A patient will be considered not eligible for enrollment into this study if any of the following criteria are met during the screening period: * Evidence of leukemic meningitis or other CNS involvement by leukemia * Uncontrolled or poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg) Note: an isolated reading that is not sustained will be permitted. * Evidence of NYHA Class III or IV cardiac disease, or presence of unstable life-threatening arrhythmia, or history of myocardial infarction during the past 6 months * Active bacterial, fungal, or viral infection requiring systemic treatment * Known infection with HIV * History or major surgery within 4 weeks before the first dose of study treatment, or not recovered from prior surgery * Exposure to any other investigational agent at any time within 4 weeks before the first dose of study treatment * Exposure to any other anti-leukemic therapy (except hydroxyurea, see Section 5.5.1) within 2 weeks before the first dose of study treatment * Pregnant or lactating female * Unwilling or unable to comply with the requirements of the study protocol