A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Lymphocytic Leukemia
In brief
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants 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.
Key facts
- Study ID
- NCT01539512
- Run by
- Gilead Sciences
- People needed
- 220
- Starts
- 2012-04-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2019-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates — Tucson, Arizona, United States
- University of California, San Diego- Moores Cancer Center — La Jolla, California, United States
- Ventura County Hematology Oncology Specialists — Oxnard, California, United States
- UCLA — Santa Monica, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Rocky Mountain Blood and Marrow Transplant Program — Denver, Colorado, United States
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- Collaborative Medical Research Corporation — Boynton Beach, Florida, United States
- Collaborative Research Group LLC — Boynton Beach, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- University of Florida — Gainesville, Florida, United States
- Florida Cancer Specialists — St. Petersburg, Florida, United States
- Winship Cancer Institute at Emory University — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Hematology Oncology Associates of Northern New Jersey — Morristown, New Jersey, United States
- Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Willamette Valley Cancer Center — Springfield, Oregon, United States
- Northwest Cancer Specialists, PC — Tualatin, Oregon, United States
- Cancer Centers of the Carolinas — Greenville, South Carolina, United States
- Clearview Cancer Institute — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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