Spots Global Cancer Trial Database for Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
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Trial Identification
Brief Title: Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Official Title: 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
Study ID: NCT01569295
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
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
UCLA Medical Center, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
University of Florida, Gainesville, Florida, United States
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Summit Medical Group, P.A., Morristown, New Jersey, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Willamette Valley Cancer Center, Eugene, Oregon, United States
Charleston Hematology Oncology, Charleston, South Carolina, United States
Texas Oncology, Austin, Texas, United States
Texas Oncology PA, Dallas, Texas, United States
Texas Oncology, Fort Worth, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Cancer Care Northwest, US Oncology, Spokane, Washington, United States
Virginia Cancer Specialists, PC, Vancouver, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
St Vincent's Hospital - Sydney, Darlinghurst, New South Wales, Australia
Gosford Hospital, Gosford, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Monash Medical Centre - Clayton Campus, Clayton, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg, Antwerpen, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Clinical Hospital "Dubrava", Zagreb, , Croatia
Klinichki Bolnicki Centar-Zagreb, Zagreb, , Croatia
University Hospital Merkur, Zagreb, , Croatia
Fakultni nemocnice Brno, Brno, , Czechia
Fakultní nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultni nemocnice Ostrava, Ostrava, , Czechia
Hopital Henri Mondor, Créteil, , France
Centre Jean Bernard - Clinique Victor Hugo, Le Mans cedex, , France
CHRU Lille-Hôpital Claude Huriez, Lille, , France
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon, , France
Centre Hospitalier de Mulhouse, Mulhouse, , France
CHU Hôtel-Dieu-Service Hématologie, Nantes, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
Hopital Purpan, Toulouse, , France
Hôpitaux de Brabois, Vandoeuvre-lés-Nancy, , France
G. Genimatas Hospital, Athens, , Greece
University General Hospital of Patras, Patras, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen, , Hungary
Tallian Gyula utca 20-32, Kaposvár, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, , Hungary
Mater Misericordiae Hospital, Dublin, , Ireland
Spedali Civili di Brescia, Brescia, , Italy
Ospedale Oncologico Regionale A. Businco, Cagliari, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette, Torino, , Italy
Szpital Specjalistyczny w Brzozowie, Brzozow, , Poland
Malopolskie Centrum Medyczne, Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin, , Poland
Wojewodzki Szpital w Opolu, Opole, , Poland
Centralny Szpital Kliniczny MSW w Warszawie, Warszawa, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Hospital Santa Maria, Lisboa, , Portugal
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE), Porto, , Portugal
Emergency County Clinical Hospital Brasov, Brasov, , Romania
"Colentina" Clinical Hospital, Bucharest, , Romania
"Fundeni" Clinical Institute, Bucharest, , Romania
Regional Oncology Institute Iasi, Iasi, , Romania
Russian Oncology Research Center (N.N. Blokhin), Moscow, , Russian Federation
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko, Nizhniy Novgorod, , Russian Federation
Novosibirsk State Regional Clinical Hospital, Novosibirsk, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
Research Institute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1, Volgograd, , Russian Federation
Hospital Universitario Germans Trias i Pujol, Badalona, Cataluña, Spain
Hospital Clinic de Barcelona, Barcelona, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain
Hospital 12 de Octubre, Madrid, Madrid, Communidad De, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Communidad De, Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Gazi University Medical Faculty Gazi Hospital, Ankara, , Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Istanbul University Istanbul Medical Faculty, Istanbul, , Turkey
Ondokuz Mayis University Faculty of Medicine, Samsun, , Turkey
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Kent and Canterbury Hospital, Canterbury, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Dorset County Hospital, Dorchester, , United Kingdom
St. James University Hospital, Leeds, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
St Bartholomews Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
University College London, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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