| Exclusion Criteria: | 1) Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term nonchemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and it's (non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment.
2) Prior treatment for AML; only hydroxyurea is permitted
3) Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
4) Patients with a prior anthracycline exposure of greater than 368 mg/m(2) daunorubicin (or equivalent)
5) Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
6) Administration of any antineoplastic or investigational therapy within 4 weeks of the first dose of study drug or during the study treatment phase; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
7) Clinical evidence of active CNS leukemia
8) Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
9) Active and uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study if they are afebrile and hemodynamically stable for >/= 72 hrs.
10) Current evidence of invasive fungal infection (blood or tissue culture); known HIV (new testing not required) or active hepatitis C infection (by rising transaminase values)
11) Hypersensitivity to cytarabine, daunorubicin or liposomal products
12) History of Wilson's disease or other copper-related disorder |