RT Journal Article
T1 Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.
A1 Roboz, Gail J
A1 Montesinos, Pau
A1 Selleslag, Dominik
A1 Wei, Andrew
A1 Jang, Jun-Ho
A1 Falantes, Jose
A1 Voso, Maria T
A1 Sayar, Hamid
A1 Porkka, Kimmo
A1 Marlton, Paula
A1 Almeida, Antonio
A1 Mohan, Sanjay
A1 Ravandi, Farhad
A1 Garcia-Manero, Guillermo
A1 Skikne, Barry
A1 Kantarjian, Hagop
K1 CC-486
K1 Phase III
K1 acute myeloid leukemia
K1 de novo
K1 elderly
K1 maintenance therapy
K1 oral azacitidine
K1 secondary
AB 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.
YR 2016
FD 2016-01-19
LK http://hdl.handle.net/10668/9745
UL http://hdl.handle.net/10668/9745
LA en
DS RISalud
RD Apr 10, 2025