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

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Date

2016-01-19

Authors

Roboz, Gail J
Montesinos, Pau
Selleslag, Dominik
Wei, Andrew
Jang, Jun-Ho
Falantes, Jose
Voso, Maria T
Sayar, Hamid
Porkka, Kimmo
Marlton, Paula

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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.

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MeSH Terms

Administration, Oral
Antimetabolites, Antineoplastic
Azacitidine
Clinical Trials, Phase III as Topic
Humans
Leukemia, Myeloid, Acute
Maintenance Chemotherapy
Middle Aged
Randomized Controlled Trials as Topic

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Keywords

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

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