A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes
Comparison/Control Interventions: The comparison is azacitidine at different doses and
schedules.
Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24
months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.
Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD). Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)
Day 1 (randomization) to 6 months
No
CL Beach
Study Director
Celgene Corporation
United States: Food and Drug Administration
AZA PH US 2004 CL 003
NCT00102687
January 2005
August 2008
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
Oncology Services of Aberdeen | Aberdeen, South Dakota 57401 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Cancer Care Northwest | Spokane, Washington 99202 |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Texas Oncology, PA | Dallas, Texas 75246-2006 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Texas Cancer Center at Medical City | Dallas, Texas 75230 |
Highline Medical Oncology | Burien, Washington 98166 |
Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
Greater Dayton Cancer Center | Kettering, Ohio 45409 |
Northwest Cancer Specialists, P.C. | Vancouver, Washington |
San Antonio Tumor & Blood Clinic | Fredericksburg, Texas 78624 |
Comprehensive Blood and Cancer Center, Research Department | Bakersfield, California 93309 |
Cancer Center of Colorado Springs, The Oncology Clinic, PC | Colorado Springs, Colorado 80907 |
Rocky Mountain Cancer Centers, LLP | Denver, Colorado 80218 |
Oncology/Hematology Associates of Central Illinois, PC | Peoria, Illinois 61615-7828 |
Hematology & Oncology Specialists LLC | Metairie, Louisiana 70115 |
Great Lakes Cancer Institute Breslin Cancer Center | Lansing, Michigan 48910 |
The Center for Cancer Care and Research | St. Louis, Missouri 63141 |
Avera Cancer Institute Leukemia-Bone Marrow Transplant Center | Sioux Falls, South Dakota 57105 |
McLeod Cancer and Blood Center | Johnson City, Tennessee 37604 |
The Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Cancer Care Centers of South Texas - HOAST | San Antonio, Texas 78229 |
Virginia Oncology Associates - Lake Wright Cancer Center | Norfolk, Virginia 23502 |
Puget Sound Cancer Center | Edmonds, Washington 98026 |