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

Gail Judith 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 M 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 Judith 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 M Kantarjian

Australian Centre for Blood Diseases

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

37 Citations (Scopus)

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
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
Publication status	Published - 1 Feb 2016

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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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. M. (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

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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.",

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

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

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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, HM 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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AU - Roboz, Gail Judith

AU - Montesinos, Pau

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AU - Wei, Andrew

AU - Jang, Jun Ho

AU - Falantes, Jose

AU - Voso, Maria T.

AU - Sayar, Hamid

AU - Porkka, Kimmo

AU - Marlton, Paula

AU - Almeida, Antonio

AU - Mohan, Sanjay

AU - Ravandi, Farhad

AU - Garcia-Manero, Guillermo

AU - Skikne, Barry

AU - Kantarjian, Hagop M

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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.

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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

UN SDGs

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