Spots Global Cancer Trial Database for Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 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 Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Study ID: NCT01732913
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to 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
City of Hope Cancer Center, Duarte, California, United States
Saint Jude Heritage Healthcare, Fullerton, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
UCLA Medical Center, Los Angeles, California, United States
Cancer Care Associates, Redondo Beach, California, United States
Cancer Center of Santa Barbara, Santa Barbara, California, United States
Central Coast Medical Oncology Group, Santa Maria, California, United States
Middlesex Hospital Cancer Center, Middletown, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists and Research Institute, Fort Myers, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Wayne State University, Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Prairie Lakes Healthcare System, Watertown, South Dakota, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Texas Oncology, P.A., Bedford, Texas, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Center for Cancer and Blood Disorders, PC, Fort Worth, Texas, United States
Shenandoah Oncology Associates, PC, Winchester, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Froedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Haematology and Oncology Clinics of Australia at Chermside, Milton, Queensland, 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
Adelaide Cancer Centre, Kurralta Park, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Fakultní nemocnice Hradec Králové, Hradec Králové, , Czechia
University Hospital of Bordeaux, Pessac, Aquitaine, France
Hôpital Necker-Enfants Malades, Paris, Ile-de-france, France
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille cedex, NORD Pas-de-calais, France
Centre Hospitalier Universitaire Brest, Brest, , France
Centre Hospitalier de Dunkerque, Dunkerque, , France
Centre Hospitalier de Versailles, Le Chesnay, , France
Centre Léon Bérard, Lyon Cedex 08, , France
Hôpital Hôtel-Dieu, Nantes cedex 1, , France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie, Poitiers Cedex, , France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen, Baden-wuerttemberg, Germany
Gemeinschaftspraxis Dres. Söling Und Siehl, Kassel, Hessen, Germany
Debreceni Egyetem Orvos-és Egészségtudományi Centrum, Debrecen, Hajdu-bihar, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, Somogy, Hungary
Markusovszky Egyetemi Oktatókórház, Szombathely, VAS, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Hadassah Medical Organization, Ein Kerem, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Centro di Riferimento Oncologico di Aviano, Pordenone, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Nagoya City University Hospital, Nagoya City, Aichi, Japan
National Hospital Organization Nagoya Medical Center, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Hospital Organization Kyushu Cancer Center, Minami Ku, Fukuoka, Japan
Kobe City Medical Center General Hospital, Kobe-city, Hyogo, Japan
Tokai University Hospital, Isehara-shi, Kanagawa, Japan
National Hospital Organization Kumamoto Medical Center, Chuo-ku, Kumamoto, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Okayama University Hospital, Okayama-city, Okayama, Japan
Osaka City University Hospital, Osaka-shi, Osaka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
Toranomon Hospital, Minato-ku, Tokyo, Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Malopolskie Centrum Medyczne S.C., Kraków, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim, Olsztyn, , Poland
Centrum Onkologii i Hipertermii, Warszawa, , Poland
Hospital Geral de Santo António do Centro Hospitalar do Porto, Porto, , Portugal
Institutul Clinic Fundeni, Bucuresti, , Romania
Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko, Nizhniy Novgorod, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , 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
Singapore General Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Gleneagles Medical Centre, Singapore, , Singapore
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Skånes Universitetssjukhus, Malmö, Malmö, , Sweden
Chang Gung Memorial Hospital (CGMH), Kaohsiung, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Barts and The London NHS Trust, London, England, United Kingdom
Mount Vernon Hospital, Middlesex, , United Kingdom
Sunderland Royal Infirmary, Sunderland, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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