Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia Cytarabine Vidaza azacitidine Intensive Chemotherapy Low Dose Cytarabine Celgene
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 488
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

Detailed description:

Arms:
arm 1: Azacitidine daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity arm 2: Conventional Care Regimen

Interventions: intervention 1: Azacitidine intervention 2: Conventional Care Regimen
Intervention descriptions: intervention 1: 75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity intervention 2: Physician pre-selects prior to randomization from one of the following:

* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
* Best Supportive Care only; until study end

Protocol document: