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

Roboz, Gail J., Montesinos, Pau, Selleslag, Dominik, Wei, Andrew, Jang, Jun-Ho, Falantes, Jose, Voso, Maria T., Sayar, Hamid, Porkka, Kimmo, Marlton, Paula, Almeida, Antonio, Mohan, Sanjay, Ravandi, Farhad, Garcia-Manero, Guillermo, Skikne, Barry and Kantarjian, Hagop (2016) Design of the randomized, Phase III, QUAZAR AML maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncology, 12 3: 293-302. doi:10.2217/fon.15.326


Author Roboz, Gail J.
Montesinos, Pau
Selleslag, Dominik
Wei, Andrew
Jang, Jun-Ho
Falantes, Jose
Voso, Maria T.
Sayar, Hamid
Porkka, Kimmo
Marlton, Paula
Almeida, Antonio
Mohan, Sanjay
Ravandi, Farhad
Garcia-Manero, Guillermo
Skikne, Barry
Kantarjian, Hagop
Title Design of the randomized, Phase III, QUAZAR AML maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia
Journal name Future Oncology   Check publisher's open access policy
ISSN 1479-6694
1744-8301
Publication date 2016-02
Year available 2016
Sub-type Article (original research)
DOI 10.2217/fon.15.326
Open Access Status Not Open Access
Volume 12
Issue 3
Start page 293
End page 302
Total pages 10
Place of publication London, United Kingdom
Publisher Future Medicine
Collection year 2017
Language eng
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
Keyword Acute myeloid leukemia
Cc-486
De novo
Elderly
Maintenance therapy
Oral azacitidine
Phase III
Secondary
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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