Spots Global Cancer Trial Database for A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Official Title: 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
Study ID: NCT01539512
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clearview Cancer Institute, Huntsville, Alabama, United States
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, 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, Saint 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
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Texas Oncology, P.A., Fort Worth, Texas, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Cancer Care Network of South Texas, San Antonio, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc, Roanoke, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Yakima Valley Memorial Hospital / North Star Lodge, Yakima, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Hôpital Henri Mondor, Creteil, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU), Lille, , France
Hôpital Emile Muller, Mulhouse, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Hôpital Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Hopital Purpan, Toulouse, , France
Gemeinschaftspraxis Hämatologie-Onkologie, Dresden, , Germany
Internistische Gemeinschaftspraxis, Erlangen, , Germany
Universitätsklinikum Köln, Köln, , Germany
Stauferklinikum Schwäb. Gmünd, Mutlangen, , Germany
Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth, Neunkirchen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Ospedale Oncologico Regionale A. Businco, Cagliari, , Italy
Ospedale San Raffaele S.r.l., Milano, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Dorset County Hospital, Dorchester, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Northwick Park Hospital, Harrow, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
King's College Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Princess Royal University Hospital, Orpington, , United Kingdom
Salisbury District Hospital, Salisbury, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Great Western Hospital, Swindon, , United Kingdom
Torbay District General Hospital, Torquay, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Yeovil District Hospital, Yeovil, , United Kingdom
Contact Details
Name: Thomas Jahn, MD
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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