A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and 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 Bendamustine and 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 bendamustine and
rituximab.
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-312-0115
NCT01569295
May 2012
December 2016
Name | Location |
---|---|
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
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 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
University of Florida | Gainesville, Florida 32610-0277 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
M.D. Anderson Cancer Center | Houston, Texas 77030 |
Providence Holy Cross Medical Center | Mission Hills, California 91345 |
Texas Oncology | Dallas, Texas |
Charleston Hematology Oncology | Charleston, South Carolina 29403 |
Hematology Oncology Associates of Northern New Jersey | Morristown, New Jersey 07960 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Minnesota Oncology Hematology, PA | Minneapolis, Minnesota 55404 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Texas Oncology PA | Dallas, Texas 75231 |
Weill Cornell Medical College | New York, New York 10021 |
Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
Cancer Care Northwest, US Oncology | Spokane, Washington 99202 |