Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Inclusion Criteria: * Able to understand and have the ability to provide written consent * Between 18 and 70 years of age * Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy * ECOG Performance Status of 0-2 * Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion. * Patients must have left ventricular ejection fraction (LVEF) ≥50% * Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception. Exclusion Criteria: * Patients with acute promyelocytic leukemia * Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin * Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML * History of thromboembolic event within the past 12 months * Hepatitis B or C or HIV positive serology * Symptomatic central nervous system (CNS) involvement * History of congestive heart failure * Myocardial infarction in the past 6 months * Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy * History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent * Patient may not be receiving any other anti neoplastic investigational agents * INR\> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin) * Patient undergone autologous or allogeneic stem cell transplantation * Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia * Women who are pregnant or breastfeeding.