Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients

Inclusion Criteria:

- Patients diagnosed with AML meeting one of the following criteria:

- Newly diagnosed, age 60 and older

- High risk cytogenetics (National Comprehensive Cancer Network [NCCN] criteria)

- Relapsed or refractory to prior chemotherapy

- Secondary AML

- Any prior therapy must have been completed >= 2 weeks prior to enrollment and the
participant must have recovered to eligibility levels from prior toxicity

- Only one prior regimen is allowed for AML patients; note one prior regimen is
defined as follows:

- Induction chemotherapy followed by consolidation is considered one regimen

- Induction chemotherapy followed by re-induction in case of persistent
disease followed by consolidation is considered one regimen

- Hydroxyurea is allowed prior to enrollment to keep white blood cell (WBC) below
20 K

- Karnofsky performance status >= 60%

- Total bilirubin < 1.5 x institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal

- Creatinine < 1.5 x institutional upper limit or normal OR creatinine clearance >= 60
mL/min for patients with creatinine levels above 1.5 x institutional upper limit of
normal

- Ejection fraction (EF) >= 45%

- Ability to understand and the willingness to sign a written informed consent document

- Patients should not be receiving any other investigational agents

Exclusion Criteria:

- Patients with clinically significant illness which would compromise participation in
the study, including, but not limited to: active or uncontrolled infection, immune
deficiencies or confirmed diagnosis of human immunodeficiency virus (HIV) infection,
active hepatitis B, active hepatitis C, or uncontrolled diabetes, uncontrolled
hypertension, symptomatic congestive heart failure, unstable angina pectoris,
myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias; or
psychiatric illness/social situations that would limit compliance with study
requirements

- Patients with additional (other than AML) currently active primary malignancy other
than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous
cell carcinoma of the skin; patients are not considered to have a "currently active"
malignancy if they have completed therapy for a prior malignancy and disease free
from prior malignancies for > 2 years

- Patients with active central nervous system (CNS) disease

- Active infections, including opportunistic infections

- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 14 days of the first administration of oral dasatinib