A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Red blood cell (RBC) transfusion independence
Red blood cell (RBC) transfusion independence
Up to 60 months
No
Barry Skikne, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
AZA-MDS-003
NCT01566695
December 2012
December 2016
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
The University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
Kaiser Permanente Northwest | Portland, Oregon 97227 |
University of Kansas Cancer Center | Kansas City, Kansas 66160 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Marin Specialty Care | Greenbrae, California 94904 |
California Cancer Associates for Research & Excellence (cCARE) | Fresno, California 93720 |
East Jefferson General Hospital C/O Cancer Care of Louisiana | Metairie, Louisiana 70006 |
Weill Cornell Medical College - New York-Presbyterian Hospital | New York, New York 10021 |
University Hospitals, Case Medical Center | Cleveland, Ohio 44106 |
Western Pennsylvania Cancer Institute, c/o Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |