Conditions: Acute Myeloid Leukemia Acute Myelogenous Leukemia
Keywords: AML elderly acute myelogenous leukemia vidaza azacitidine elderly AML revlimid lenalidomide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

Brief summary:
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Detailed description:
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Arms:
arm 1: Repeated cycles of azacitidine 75 mg/m\^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care arm 2: Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care arm 3: Repeated cycles of azacitidine 75mg/m\^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care

Interventions: intervention 1: Azacitidine intervention 2: Lenalidomide intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7 intervention 2: Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily intervention 3: The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support

Protocol document: