Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia

Exclusion Criteria

• •Prior cytotoxic therapy for AML or MDS (hydroxyurea or similar low-dose therapy to control the white count prior to initiation of induction therapy \[i.e., start of ara-C administration\] is not an exclusion);
• •Diagnosis of acute promyelocytic leukemia (FAB M3 AML);
• •Prior diagnosis of AHD (Antecedent Hematologic Disorder, e.g. Polycythemia Vera);
• •Known central nervous system (CNS) involvement;
• •Life expectancy, in the opinion of the Investigator, of \< 3 months due to co-morbid conditions unrelated to AML;
• •History of prior malignancies within the last six (6 mos.) that have required the administration of systemic cytotoxic chemotherapy or other systemic bone marrow cytotoxic agents or therapies,or radiation therapy of any kind to areas of the body containing bone marrow;
• •History of prior anthracycline use;
• •Prior treatment with other investigational agents within 4 weeks prior to entry or randomization;
• •Current or planned participation (from the day of entry or randomization through 30 days after the last dose of ara-C therapy) in a research protocol in which an investigational agent or therapy may be administered;
• •Infection with human immunodeficiency virus (HIV) or active viral hepatic infections based on patient's medical history elicited by the Investigator within 5 days prior to entry or randomization;
• •Any evidence of or history elicited by the Investigator of angina, acute or chronic congestive heart failure, or pericardial effusion within 6 months prior to entry or randomization;
• •Any evidence of or history elicited by the Investigator of uncontrolled or refractory hypertension despite medication within 6 months prior to entry or randomization;
• •Any evidence of or history elicited by the Investigator of a myocardial infarction within the last 6 months prior to randomization;
• •Any evidence of cerebrovascular accident (CVA) with unstable neural deficits within 6 months prior to entry or randomization.
• •Any evidence of transient ischemia attack (TIA) or symptomatic cerebrovascular disease within 6 months prior to entry or randomization;
• •Any evidence of clinically significant cardiac arrhythmia including prolongation of QT interval that cannot be controlled with medication or is unstable or symptomatic within 2 months prior to entry or randomization;
• •A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the Investigator, might not permit the patient to complete the study or sign the informed consent.