Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Roboz GJ
- 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
Grupos
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.
Datos de la publicación
- ISSN/ISSNe:
- 1479-6694, 1744-8301
- Tipo:
- Article
- Páginas:
- 293-302
- DOI:
- 10.2217/fon.15.326
- PubMed:
- 26785287
- Factor de Impacto:
- 0,752 SCImago ℠
- Cuartil:
- Q2 SCImago ℠
Future Oncology TAYLOR & FRANCIS LTD
Citas Recibidas en Web of Science: 35
Documentos
- No hay documentos
Filiaciones
Keywords
- acute myeloid leukemia; CC-486; de novo; elderly; maintenance therapy; oral azacitidine; Phase III; secondary
Portal de investigación