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

Gail J. Roboz; Pau Montesinos; Dominik Selleslag; Andrew Wei; Jun Ho Jang; Jose Falantes; Maria T. Voso; Hamid Sayar; Kimmo Porkka; Paula Marlton; Antonio Almeida; Sanjay Mohan; Farhad Ravandi; Guillermo Garcia-Manero; Barry Skikne; Hagop Kantarjian

doi:10.2217/fon.15.326

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

Gail J. Roboz, Pau Montesinos, Dominik Selleslag, Andrew Wei, Jun Ho Jang, Jose Falantes, Maria T. Voso, Hamid Sayar, Kimmo Porkka, Paula Marlton, Antonio Almeida, Sanjay Mohan, Farhad Ravandi, Guillermo Garcia-Manero, Barry Skikne, Hagop Kantarjian

Leukemia

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

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.

Original language	English (US)
Pages (from-to)	293-302
Number of pages	10
Journal	Future Oncology
Volume	12
Issue number	3
DOIs	https://doi.org/10.2217/fon.15.326
State	Published - Feb 2016

Keywords

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

ASJC Scopus subject areas

Oncology
Cancer Research

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10.2217/fon.15.326

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Roboz, G. J., Montesinos, P., Selleslag, D., Wei, A., Jang, J. H., Falantes, J., Voso, M. T., Sayar, H., Porkka, K., Marlton, P., Almeida, A., Mohan, S., Ravandi, F., Garcia-Manero, G., Skikne, B., & Kantarjian, H. (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. https://doi.org/10.2217/fon.15.326

Roboz, GJ, Montesinos, P, Selleslag, D, Wei, A, Jang, JH, Falantes, J, Voso, MT, Sayar, H, Porkka, K, Marlton, P, Almeida, A, Mohan, S, Ravandi, F , Garcia-Manero, G, Skikne, B & Kantarjian, H 2016, 'Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia', Future Oncology, vol. 12, no. 3, pp. 293-302. https://doi.org/10.2217/fon.15.326

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

Abstract

Keywords

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