%0 Journal Article
%A Roboz, Gail J
%A Montesinos, Pau
%A Selleslag, Dominik
%A Wei, Andrew
%A Jang, Jun-Ho
%A Falantes, Jose
%A Voso, Maria T
%A Sayar, Hamid
%A Porkka, Kimmo
%A Marlton, Paula
%A Almeida, Antonio
%A Mohan, Sanjay
%A Ravandi, Farhad
%A Garcia-Manero, Guillermo
%A Skikne, Barry
%A Kantarjian, Hagop
%T Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.
%D 2016
%U http://hdl.handle.net/10668/9745
%X 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.
%K CC-486
%K Phase III
%K acute myeloid leukemia
%K de novo
%K elderly
%K maintenance therapy
%K oral azacitidine
%K secondary
%~