|Ages Eligible for Study:||18 Years to 70 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Provide signed, dated informed consent prior to any protocol-specific procedures.
- Have a diagnosis of previously-untreated AML, defined as >20% myeloblasts on the marrow aspirate or peripheral blood differential, with or without extramedullary involvement, with confirmatory immunophenotyping or immunocytochemistry (e.g., myeloperoxidase), documented within 14 days of enrollment
- Have Eastern Cooperative Oncology Group (ECOG) performance status (Appendix A) score of 0, 1, or 2.
- Toxicities from all prior treatments have resolved to baseline or δ Grade 1 prior to first dose of study drugs.
- Are surgically or biologically sterile or willing to practice acceptable birth control, as follows: Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
- Males must agree to abstain from sexual activity or agree to utilize a medially-approved contraception method during and for 3 months afer the treatment period.
- Have adequate renal and hepatic function, as indicated by the following laboratory values: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) δ2.5 - upper limit of normal (ULN); Estimated creatinine clearance (CrCl) of > 50mL/min, as calculated by the Cockcroft-Gault equation (Appendix F); total bilirubin δ1.5-ULN (except in patients with Gilbert Syndrome, in whom direct bilirubin must be δ1.5-ULN), International Normalized Ratio (INR) δ1.5
- Have adequate cardiac function, as measured by left ventricular ejection fraction (LVEF) ε40% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan
- Be able to comply with study procedures and follow-up examinations.