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

Fecha de publicación:

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

Future Oncology  TAYLOR & FRANCIS LTD

Tipo:
Article
Páginas:
293-302
PubMed:
26785287
Factor de Impacto:
0,752 SCImago
Cuartil:
Q2 SCImago

Citas Recibidas en Web of Science: 35

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Keywords

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

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