Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia Dacogen Decitabine Poor or intermediate-risk cytogenetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 485
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Detailed description:

Arms:
arm 1: Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) arm 2: None

Interventions: intervention 1: Cytarabine or Supportive Care intervention 2: Dacogen (decitabine) only
Intervention descriptions: intervention 1: Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.) intervention 2: 20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.

Protocol document: