Journal
FUTURE ONCOLOGY
Volume 12, Issue 3, Pages 293-302Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/fon.15.326
Keywords
acute myeloid leukemia; CC-486; de novo; elderly; maintenance therapy; oral azacitidine; Phase III; secondary
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Funding
- Celgene Corporation
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Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged >= 55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.
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