title: Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.
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.
authors.affiliation: Weill Medical College of Cornell University & New York-Presbyterian Hospital, New York, NY, USA.
authors.forename: Gail J
authors.initials: GJ
authors.lastname: Roboz
authors.affiliation: Hospital Univeritari I Politecnic La Fe de Valencia, Valencia, Spain.
authors.forename: Pau
authors.initials: P
authors.lastname: Montesinos
authors.affiliation: AZ Sint-Jan AV, Brugge, Belgium.
authors.forename: Dominik
authors.initials: D
authors.lastname: Selleslag
authors.affiliation: The Alfred Hospital & Monash University, Melbourne, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Wei
authors.affiliation: Samsung Medical Center, Seoul, South Korea.
authors.forename: Jun-Ho
authors.initials: JH
authors.lastname: Jang
authors.affiliation: Hospital Universitario Virgen del Rocio & Instituto de Biomedicinia de Sevilla, Seville, Spain.
authors.forename: Jose
authors.initials: J
authors.lastname: Falantes
authors.affiliation: Universita Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Maria T
authors.initials: MT
authors.lastname: Voso
authors.affiliation: Indiana University Cancer Center, Indianapolis, IN, USA.
authors.forename: Hamid
authors.initials: H
authors.lastname: Sayar
authors.affiliation: Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Kimmo
authors.initials: K
authors.lastname: Porkka
authors.affiliation: Princess Alexandra Hospital, University of Queensland School of Medicine, Brisbane, Australia.
authors.forename: Paula
authors.initials: P
authors.lastname: Marlton
authors.affiliation: Instituto Portugues de Oncologia Francisco Gentil, Lisbon, Portugal.
authors.forename: Antonio
authors.initials: A
authors.lastname: Almeida
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mohan
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Farhad
authors.initials: F
authors.lastname: Ravandi
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Garcia-Manero
authors.affiliation: Celgene Corporation, Overland Park, KS, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Skikne
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
mesh_terms: D000284:Administration, Oral; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001374:Azacitidine / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D060046:Maintenance Chemotherapy; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine
keywords: CC-486; Phase III; acute myeloid leukemia; de novo; elderly; maintenance therapy; oral azacitidine; secondary