Validation of an in Vitro Assay to Predict Targeted Therapies for Acute Leukemia Patients

Inclusion Criteria:

• Patients with relapsed/refractory leukemia with a confirmed diagnosis of acute myelogenous leukemia or acute lymphoblastic leukemia who have in vitro kinase inhibitor sensitivity as determined by our functional kinase inhibitor screen
• Patients have relapsed and are refractory to at least 1 cycle of salvage therapy
• Patients have not received leukemia treatment within 2 weeks of starting study drug
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
• Patients must have normal organ function as defined by protocol
• Normal corrected QT (QTc) interval on screening electrocardiogram (ECG) evaluation
• Discontinuation of any medications known to contribute significantly to the risk of QT prolongation up to 48 hours prior to start of study drug
• Discontinuation of anti-coagulants and anti-platelet drugs up to 5 days prior to start of study drug
• No uncontrolled infections as determined by the investigator
• No uncontrolled thyroid disease
• No active graft-versus-host disease (GVHD)
• Must be able to take oral medication
• Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
• Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped. Women of childbearing potential and men with a significant other of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
• Ability to understand and the willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) document

Exclusion Criteria:

• Patients may not receive concurrent chemotherapy, radiotherapy or immunotherapy, nor have received any other investigational agents within the last 14 days of start of screening
• Patients may not have pleural or pericardial effusion of any grade
• Known pulmonary arterial hypertension (dasatinib subjects only)
• Uncontrolled angina, greater than New York Heart Association (NYHA) class III congestive heart failure or myocardial infarction within 6 months prior to study enrollment
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias
• Subjects with hypokalemia or hypomagnesemia that cannot be corrected prior to kinase inhibitor administration
• History of significant bleeding disorder unrelated to cancer.
• Concomitant medications that are generally accepted to have a risk of causing Torsades de Pointes.
• Drugs that affect the Cytochrome P450 3A4 (CYP3A4) system (inducers/inhibitors/substrates) are allowed but should be used with caution depending on specific kinase inhibitor used.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant
• Known Human immunodeficiency virus (HIV) positive patients are excluded from the study because of possible risk of lethal infection when treated with marrow suppressive therapy.