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

Author:

Roboz Gail J1,Montesinos Pau2,Selleslag Dominik3,Wei Andrew4,Jang Jun-Ho5,Falantes Jose6,Voso Maria T7,Sayar Hamid8,Porkka Kimmo9,Marlton Paula10,Almeida Antonio11,Mohan Sanjay12,Ravandi Farhad13,Garcia-Manero Guillermo13,Skikne Barry14,Kantarjian Hagop13

Affiliation:

1. Weill Medical College of Cornell University & New York-Presbyterian Hospital, New York, NY, USA

2. Hospital Univeritari I Politecnic La Fe de Valencia, Valencia, Spain

3. AZ Sint-Jan AV, Brugge, Belgium

4. The Alfred Hospital & Monash University, Melbourne, Australia

5. Samsung Medical Center, Seoul, South Korea

6. Hospital Universitario Virgen del Rocio & Instituto de Biomedicinia de Sevilla, Seville, Spain

7. Universita Cattolica del Sacro Cuore, Rome, Italy

8. Indiana University Cancer Center, Indianapolis, IN, USA

9. Helsinki University Central Hospital, Helsinki, Finland

10. Princess Alexandra Hospital, University of Queensland School of Medicine, Brisbane, Australia

11. Instituto Portugues de Oncologia Francisco Gentil, Lisbon, Portugal

12. Vanderbilt University Medical Center, Nashville, TN, USA

13. The University of Texas MD Anderson Cancer Center, Houston, TX, USA

14. Celgene Corporation, Overland Park, KS, USA

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.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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