A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the
Efficacy and Safety of Idelalisib (GS-1101) in Combination with Rituximab for Previously
Treated Chronic Lymphocytic Leukemia.
Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to
receive either Idelalisib or placebo. All subjects will be administered rituximab. Subjects
who are tolerating primary study therapy but experience definitive CLL progression are
eligible to receive active Idelalisib therapy in the extension study, GS-US-312-0117.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival
18 Months
No
Thomas Jahn, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
GS-US-312-0116
NCT01539512
February 2012
December 2015
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Northwestern University | Chicago, Illinois 60611 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
University of Florida | Gainesville, Florida 32610-0277 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
M.D. Anderson Cancer Center | Houston, Texas 77030 |
Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
UCLA | Los Angeles, California 90095 |
Hematology Oncology Associates of Northern New Jersey | Morristown, New Jersey 07960 |
Georgetown University Medical Center Lombardi Cancer Center | Washington, District of Columbia 20007 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Cancer Care Network of South Texas | San Antonio, Texas 78229 |
Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
Weill Cornell Medical College | New York, New York 10021 |
Rocky Mountain Blood and Marrow Transplant Program | Denver, Colorado 80218 |
Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
Yakima Valley Memorial Hospital / North Star Lodge | Yakima, Washington 98902 |
Virginia Cancer Specialists, PC | Fairfax, Virginia 22031 |
Collaborative Research Group LLC | Boynton Beach, Florida 33435 |
Oncology and Hematology Associates of Southwest Virginia, Inc | Roanoke, Virginia 24014 |
University of California, San Diego- Moores Cancer Center | La Jolla, California 92093 |