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.

Roboz, G., Montesinos, P., Selleslag, D., Wei, A., Jang, J., Falantes, J., et al. (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 [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

VOSO, MARIA TERESA;
2016-02-01

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.
feb-2016
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/15 - MALATTIE DEL SANGUE
English
CC-486; Phase III; acute myeloid leukemia; de novo; elderly; maintenance therapy; oral azacitidine; secondary
Roboz, G., Montesinos, P., Selleslag, D., Wei, A., Jang, J., Falantes, J., et al. (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 [10.2217/fon.15.326].
Roboz, G; Montesinos, P; Selleslag, D; Wei, A; Jang, J; Falantes, J; Voso, Mt; Sayar, H; Porkka, K; Marlton, P; Almeida, A; Mohan, S; Ravandi, F; Garcia Manero, G; Skikne, B; Kantarjian, H
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/162735
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