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

Gail Judith Roboz, Pau Montesinos, Dominik Selleslag, Andrew Wei, Jun Ho Jang, Jose Falantes, Maria T. Voso, Hamid Sayar, Kimmo Porkka, Paula Marlton, Antonio Almeida, Sanjay Mohan, Farhad Ravandi, Guillermo Garcia-Manero, Barry Skikne, Hagop M Kantarjian

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22 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)293-302
Number of pages10
JournalFuture Oncology
Volume12
Issue number3
DOIs
Publication statusPublished - 1 Feb 2016

Keywords

  • acute myeloid leukemia
  • CC-486
  • de novo
  • elderly
  • maintenance therapy
  • oral azacitidine
  • Phase III
  • secondary

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