Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia
| Autor: | Jun Ho Jang, Antonio Almeida, Gail J. Roboz, Dominik Selleslag, Paula Marlton, Maria Teresa Voso, Hagop M. Kantarjian, Jose F Falantes, Pau Montesinos, Sanjay R. Mohan, Guillermo Garcia-Manero, Barry S. Skikne, Farhad Ravandi, Kimmo Porkka, Andrew H. Wei, Hamid Sayar |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Oncology
Gerontology de novo Antimetabolites Antineoplastic Cancer Research medicine.medical_specialty Clinical Trial Protocol maintenance therapy oral azacitidine Azacitidine Administration Oral acute myeloid leukemia elderly Oral Azacitidine Group B Maintenance Chemotherapy 03 medical and health sciences Phase III 0302 clinical medicine Maintenance therapy Older patients Quality of life hemic and lymphatic diseases Internal medicine Clinical endpoint Humans Medicine Randomized Controlled Trials as Topic CC-486 secondary business.industry Myeloid leukemia General Medicine Middle Aged Leukemia Myeloid Acute Clinical Trials Phase III as Topic 030220 oncology & carcinogenesis business Settore MED/15 - Malattie del Sangue 030215 immunology medicine.drug |
| Zdroj: | Future Oncology FUTURE ONCOLOGY r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 1744-8301 1479-6694 |
| DOI: | 10.2217/fon.15.326 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|