Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia

Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.


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.

Trial registration: NCT01757535.

Keywords: CC-486; Phase III; acute myeloid leukemia; de novo; elderly; maintenance therapy; oral azacitidine; secondary.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Azacitidine / administration & dosage*
  • Clinical Trials, Phase III as Topic
  • Humans
  • Leukemia, Myeloid, Acute / drug therapy*
  • Maintenance Chemotherapy
  • Middle Aged
  • Randomized Controlled Trials as Topic


  • Antimetabolites, Antineoplastic
  • Azacitidine

Associated data