Spots Global Cancer Trial Database for Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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Trial Identification
Brief Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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 Indolent Non-Hodgkin Lymphomas
Study ID: NCT01732926
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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
Ironwood Cancer and Research Center, Chandler, Arizona, United States
Comprehensive Blood and Cancer Center (Bakersfield), Bakersfield, California, United States
Saint Jude Heritage Healthcare (TORI), Fullerton, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Cancer Care Associates, Redondo Beach, California, United States
San Luis Obispo Oncology and Hematology, San Luis Obispo, California, United States
Cancer Center of Santa Barbara, Santa Barbara, California, United States
Central Coast Medical Oncology Group, Santa Maria, California, United States
St Joseph Heritage Healthcare System, Santa Rosa, California, United States
Kaiser Permanente Vallejo Medical Center, Vallejo, California, United States
Sylvester Comprehensive Cancer Center/UMHC, Deerfield Beach, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Joliet Oncology Hematology Associates Ltd., Joliet, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
North Shore Hematology/Oncology Associates, East Setauket, New York, United States
Weill Cornell Medical College, New York, New York, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Bon Secours Saint Francis Hospital, Greenville, South Carolina, United States
Texas Oncology, P.A., Bedford, Texas, United States
Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology, P.A., Denton, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Texas Oncology, P.A., Harlingen, Texas, United States
Texas Oncology, P.A., Weslaco, Texas, United States
Swedish Medical Center, Seattle, Washington, United States
Northwest Medical Specialists, Tacoma, Washington, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Haematology and Oncology Clinics of Australia Gold Coast, South Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Saint Vincent's Hospital, Fitzroy, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Tom Baker Cancer Center, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Fraser Clinical Trials, Inc., New Westminster, British Columbia, Canada
BC Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Hôpital Charles Lemoyne, Greenfield Park, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Centre Hospitalier Affilie Universitaire de Quebec, Quebec, , Canada
CancerCare Manitoba, Winnipeg, , Canada
Fakultní Nemocnice Ostrava, Ostrava - Poruba, Severomoravsky KRAJ, Czechia
Fakultní nemocnice Brno, Brno, , Czechia
Fakultní nemocnice Hradec Králové, Hradec Králové, , Czechia
CHR Metz, Metz Cedex 03, Alsace, France
Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre, Strasbourg Cedex, Alsace, France
Institut Bergonié, Bordeaux Cedex, Aquitaine, France
Centre Henri-Becquerel, Rouen Cedex 1, Haute-normandie, France
Hôpital Necker-Enfants Malades, Paris, Ile-de-france, France
Centre Jean Bernard, Le Mans, PAYS DE LA Loire, France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, Rhone-alpes, France
Centre Hospitalier Universitaire Brest, Brest Cedex, , France
Centre Hospitalier de Dunkerque, Dunkerque, , France
Centre Hospitalier Départmental La Roche sur Yon, La Roche sur Yon, , France
Centre Léon Bérard, Lyon Cedex 08, , France
Institut Paoli Calmettes, Marseille, , France
Hôpital Hôtel-Dieu, Nantes cedex 1, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers Cedex, , France
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen, Baden-wuerttemberg, Germany
Gemeinschaftspraxis Dres. Söling Und Siehl, Kassel, Hessen, Germany
Vivantes Klinikum am Urban, Berlin, , Germany
Charite - Campus Virchow, Berlin, , Germany
Klinikum der Ludwig-Maximilians-Universität München, München, , Germany
Barzilai Medical Center, Ashkelon, , Israel
Soroka University Medical Center, Beer Sheva, , Israel
Rambam Health Corp., Haifa, , Israel
Hadassah Medical Organization, Ein Kerem, Jerusalem, , Israel
Centro di Riferimento Oncologico di Aviano, Aviano, , Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Spedali Civili Di Brescia Azienda Ospedaliera, Brescia, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Ospedale San Raffaele-IRCCS, Milano, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milano, , Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte, Siena, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Dong-A University Medical Center, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Malopolskie Centrum Medyczne S.C., Kraków, , Poland
Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku, Lublin, , Poland
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi, Lódz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim, Olsztyn, , Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku, Slupsk, , Poland
Centralny Szpital Kliniczny MSW w Warszawie, Warszawa, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Centrum Onkologii i Hipertermii, Warszawa, , Poland
Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
Central City Hospital # 7, Ekaterinburg, , Russian Federation
N. N. Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, Nizhniy Novgorod, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology, Saint Petersburg, , Russian Federation
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies", Saint Petersburg, , Russian Federation
Saint Petersburg I.P. Pavlov State Medical University, Saint-Petersburg, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1", Volgograd, , Russian Federation
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario de Canarias, San Cristobal de La Laguna, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fé de Valencia, Valencia, , Spain
Karolinska Universitetssjukhuset, Huddinge, Stockholm, Sweden
Länssjukhuset Ryhov, Jönköping, , Sweden
Changhua Christian Hospital, Changhua city, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng-Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Kent and Canterbury Hospital, Canterbury, England, United Kingdom
University Hospital Coventry, Coventry, England, United Kingdom
Royal Bournemouth General Hospital, Dorset, England, United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, England, United Kingdom
Barts and The London NHS Trust, London, England, United Kingdom
University College London Hospitals National Health Society Foundation Trust, London, England, United Kingdom
Guys and Saint Thomas NHS Foundation Trust, London, England, United Kingdom
Imperial College Healthcare NHS Trust, London, England, United Kingdom
Maidstone Hospital, Maidstone, England, United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, England, United Kingdom
Oxford University Hospitals NHS Trust, Oxford, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Mount Vernon Hospital, Middlesex, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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