Non Hodgkin Lymphoma Clinical Trial
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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).
View Eligibility Criteria
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following
Follicular lymphoma (FL) Grade 1, 2, or 3a
Small lymphocytic lymphoma (SLL)
Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
Key Exclusion Criteria:
History of lymphoid malignancy other than those allowed per inclusion criteria.
Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
Prior treatment with bendamustine that was not effective.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 144 Locations for this study
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Clearview Cancer Institute
Huntsville Alabama, 35805, United States
Huntsville Alabama, 35805, United States
Ironwood Cancer and Research Center
Chandler Arizona, 85224, United States
Chandler Arizona, 85224, United States
Comprehensive Blood and Cancer Center (Bakersfield)
Bakersfield California, 93309, United States
Bakersfield California, 93309, United States
Saint Jude Heritage Healthcare (TORI)
Fullerton California, 92835, United States
Fullerton California, 92835, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Long Beach California, 90813, United States
Cancer Care Associates
Redondo Beach California, 90277, United States
Redondo Beach California, 90277, United States
San Luis Obispo Oncology and Hematology
San Luis Obispo California, 93401, United States
San Luis Obispo California, 93401, United States
Cancer Center of Santa Barbara
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Central Coast Medical Oncology Group
Santa Maria California, 93454, United States
Santa Maria California, 93454, United States
St Joseph Heritage Healthcare System
Santa Rosa California, 95403, United States
Santa Rosa California, 95403, United States
Kaiser Permanente Vallejo Medical Center
Vallejo California, 94589, United States
Vallejo California, 94589, United States
Sylvester Comprehensive Cancer Center/UMHC
Deerfield Beach Florida, 33442, United States
Deerfield Beach Florida, 33442, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
Jacksonville Florida, 32256, United States
Northwest Georgia Oncology Centers, PC
Marietta Georgia, 30060, United States
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Joliet Oncology Hematology Associates Ltd.
Joliet Illinois, 60435, United States
Joliet Illinois, 60435, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08901, United States
North Shore Hematology/Oncology Associates
East Setauket New York, 11733, United States
East Setauket New York, 11733, United States
Weill Cornell Medical College
New York New York, 10065, United States
New York New York, 10065, United States
Signal Point Clinical Research Center, LLC
Middletown Ohio, 45042, United States
Middletown Ohio, 45042, United States
Hollings Cancer Center
Charleston South Carolina, 29425, United States
Charleston South Carolina, 29425, United States
Bon Secours Saint Francis Hospital
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29607, United States
Texas Oncology, P.A.
Bedford Texas, 76022, United States
Bedford Texas, 76022, United States
Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Dallas Texas, 75246, United States
Texas Oncology, P.A.
Denton Texas, 76210, United States
Denton Texas, 76210, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
Fort Sam Houston Texas, 78234, United States
Texas Oncology, P.A.
Harlingen Texas, 78550, United States
Harlingen Texas, 78550, United States
Texas Oncology, P.A.
Weslaco Texas, 78596, United States
Weslaco Texas, 78596, United States
Swedish Medical Center
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Northwest Medical Specialists
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Aurora BayCare Medical Center
Green Bay Wisconsin, 54308, United States
Green Bay Wisconsin, 54308, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53226, United States
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia
Randwick New South Wales, 2031, Australia
Haematology and Oncology Clinics of Australia Gold Coast
South Brisbane Queensland, 4101, Australia
South Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Kurralta Park South Australia, 5037, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Box Hill Victoria, 3128, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Clayton Victoria, 3168, Australia
Saint Vincent's Hospital
Fitzroy Victoria, 3065, Australia
Fitzroy Victoria, 3065, Australia
Western Hospital
Footscray Victoria, 3011, Australia
Footscray Victoria, 3011, Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Perth Western Australia, 6000, Australia
Tom Baker Cancer Center
Calgary Alberta, T2N 2, Canada
Calgary Alberta, T2N 2, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Edmonton Alberta, T6G 1, Canada
Fraser Clinical Trials, Inc.
New Westminster British Columbia, V3L 3, Canada
New Westminster British Columbia, V3L 3, Canada
BC Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
Halifax Nova Scotia, B3H 1, Canada
Halifax Nova Scotia, B3H 1, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
Barrie Ontario, L4M 6, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M4N 3, Canada
Hôpital Charles Lemoyne
Greenfield Park Quebec, J4V 2, Canada
Greenfield Park Quebec, J4V 2, Canada
McGill University Health Centre
Montréal Quebec, H4A 3, Canada
Montréal Quebec, H4A 3, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke Quebec, J1H 5, Canada
Sherbrooke Quebec, J1H 5, Canada
Centre Hospitalier Affilie Universitaire de Quebec
Quebec , G1J 1, Canada
Quebec , G1J 1, Canada
CancerCare Manitoba
Winnipeg , R3E 0, Canada
Winnipeg , R3E 0, Canada
Fakultnà Nemocnice Ostrava
Ostrava - Poruba Severomoravsky KRAJ, 708 5, Czechia
Ostrava - Poruba Severomoravsky KRAJ, 708 5, Czechia
Fakultnà nemocnice Brno
Brno , 625 0, Czechia
Brno , 625 0, Czechia
Fakultnà nemocnice Hradec Králové
Hradec Králové , 500 0, Czechia
Hradec Králové , 500 0, Czechia
CHR Metz
Metz Cedex 03 Alsace, 57085, France
Metz Cedex 03 Alsace, 57085, France
Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
Strasbourg Cedex Alsace, 67098, France
Strasbourg Cedex Alsace, 67098, France
Institut Bergonié
Bordeaux Cedex Aquitaine, 33076, France
Bordeaux Cedex Aquitaine, 33076, France
Centre Henri-Becquerel
Rouen Cedex 1 Haute-normandie, 76038, France
Rouen Cedex 1 Haute-normandie, 76038, France
Hôpital Necker-Enfants Malades
Paris Ile-de-france, 75015, France
Paris Ile-de-france, 75015, France
Centre Jean Bernard
Le Mans PAYS DE LA Loire, 72000, France
Le Mans PAYS DE LA Loire, 72000, France
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex Rhone-alpes, 69495, France
Pierre Bénite Cedex Rhone-alpes, 69495, France
Centre Hospitalier Universitaire Brest
Brest Cedex , 29609, France
Brest Cedex , 29609, France
Centre Hospitalier de Dunkerque
Dunkerque , 59385, France
Dunkerque , 59385, France
Centre Hospitalier Départmental La Roche sur Yon
La Roche sur Yon , 85925, France
La Roche sur Yon , 85925, France
Centre Léon Bérard
Lyon Cedex 08 , 69373, France
Lyon Cedex 08 , 69373, France
Institut Paoli Calmettes
Marseille , 13273, France
Marseille , 13273, France
Hôpital Hôtel-Dieu
Nantes cedex 1 , 44093, France
Nantes cedex 1 , 44093, France
Centre Hospitalier Universitaire de Poitiers
Poitiers Cedex , 86021, France
Poitiers Cedex , 86021, France
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
Tours , 37044, France
Tours , 37044, France
Institut Gustave Roussy
Villejuif , 94805, France
Villejuif , 94805, France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen Baden-wuerttemberg, 78054, Germany
Villingen-Schwenningen Baden-wuerttemberg, 78054, Germany
Gemeinschaftspraxis Dres. Söling Und Siehl
Kassel Hessen, 34117, Germany
Kassel Hessen, 34117, Germany
Vivantes Klinikum am Urban
Berlin , 10967, Germany
Berlin , 10967, Germany
Charite - Campus Virchow
Berlin , 13353, Germany
Berlin , 13353, Germany
Klinikum der Ludwig-Maximilians-Universität München
München , 81377, Germany
München , 81377, Germany
Barzilai Medical Center
Ashkelon , 78278, Israel
Ashkelon , 78278, Israel
Soroka University Medical Center
Beer Sheva , 84101, Israel
Beer Sheva , 84101, Israel
Rambam Health Corp.
Haifa , 31096, Israel
Haifa , 31096, Israel
Hadassah Medical Organization, Ein Kerem
Jerusalem , 91120, Israel
Jerusalem , 91120, Israel
Centro di Riferimento Oncologico di Aviano
Aviano , 33081, Italy
Aviano , 33081, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Bologna , 40138, Italy
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia , 25123, Italy
Brescia , 25123, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova , 16132, Italy
Genova , 16132, Italy
Ospedale San Raffaele-IRCCS
Milano , 20132, Italy
Milano , 20132, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milano , 20162, Italy
Milano , 20162, Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
Novara , 28100, Italy
Novara , 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro , 61122, Italy
Pesaro , 61122, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza , 29100, Italy
Piacenza , 29100, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena , 53100, Italy
Siena , 53100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Torino , 10126, Italy
Dong-A University Medical Center
Busan , 602-7, Korea, Republic of
Busan , 602-7, Korea, Republic of
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Gdansk , 80-95, Poland
Malopolskie Centrum Medyczne S.C.
Kraków , 30-51, Poland
Kraków , 30-51, Poland
Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
Lublin , 20-08, Poland
Lublin , 20-08, Poland
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
Lódz , 93-51, Poland
Lódz , 93-51, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn , 10-22, Poland
Olsztyn , 10-22, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Slupsk , 76-20, Poland
Slupsk , 76-20, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa , 02-50, Poland
Warszawa , 02-50, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Warszawa , 02-77, Poland
Centrum Onkologii i Hipertermii
Warszawa , 02-78, Poland
Warszawa , 02-78, Poland
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg , 62010, Russian Federation
Ekaterinburg , 62010, Russian Federation
Central City Hospital # 7
Ekaterinburg , 62013, Russian Federation
Ekaterinburg , 62013, Russian Federation
N. N. Blokhin Russian Cancer Research Center
Moscow , 11547, Russian Federation
Moscow , 11547, Russian Federation
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod , 60312, Russian Federation
Nizhniy Novgorod , 60312, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39003, Russian Federation
Ryazan , 39003, Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg , 19102, Russian Federation
Saint Petersburg , 19102, Russian Federation
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
Saint Petersburg , 19734, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint Petersburg I.P. Pavlov State Medical University
Saint-Petersburg , 19702, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Saratov State Medical University
Saratov , 14001, Russian Federation
Saratov , 14001, Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
Volgograd , 40013, Russian Federation
Volgograd , 40013, Russian Federation
Hospital Universitario Puerta de Hierro
Majadahonda Madrid, 28222, Spain
Majadahonda Madrid, 28222, Spain
Hospital Universitari Germans Trias i Pujol
Badalona , 08916, Spain
Badalona , 08916, Spain
Hospital Universitario La Princesa
Madrid , 28006, Spain
Madrid , 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Madrid , 28007, Spain
Hospital ClÃnico Universitario de Salamanca
Salamanca , 37007, Spain
Salamanca , 37007, Spain
Hospital Universitario de Canarias
San Cristobal de La Laguna , 38320, Spain
San Cristobal de La Laguna , 38320, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Sevilla , 41013, Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia , 46026, Spain
Valencia , 46026, Spain
Karolinska Universitetssjukhuset
Huddinge Stockholm, 141 8, Sweden
Huddinge Stockholm, 141 8, Sweden
Länssjukhuset Ryhov
Jönköping , 551 8, Sweden
Jönköping , 551 8, Sweden
Changhua Christian Hospital
Changhua city , 500, Taiwan
Changhua city , 500, Taiwan
China Medical University Hospital
Taichung , 404, Taiwan
Taichung , 404, Taiwan
National Cheng-Kung University Hospital
Tainan , 70403, Taiwan
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei , 10002, Taiwan
Kent and Canterbury Hospital
Canterbury England, CT1 3, United Kingdom
Canterbury England, CT1 3, United Kingdom
University Hospital Coventry
Coventry England, CV2 2, United Kingdom
Coventry England, CV2 2, United Kingdom
Royal Bournemouth General Hospital
Dorset England, BH7 7, United Kingdom
Dorset England, BH7 7, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds England, LS9 7, United Kingdom
Leeds England, LS9 7, United Kingdom
Barts and The London NHS Trust
London England, EC1M , United Kingdom
London England, EC1M , United Kingdom
University College London Hospitals National Health Society Foundation Trust
London England, NW1 2, United Kingdom
London England, NW1 2, United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London England, SE1 9, United Kingdom
London England, SE1 9, United Kingdom
Imperial College Healthcare NHS Trust
London England, W12 0, United Kingdom
London England, W12 0, United Kingdom
Maidstone Hospital
Maidstone England, ME16 , United Kingdom
Maidstone England, ME16 , United Kingdom
Christie Hospital NHS Foundation Trust
Manchester England, M20 4, United Kingdom
Manchester England, M20 4, United Kingdom
Oxford University Hospitals NHS Trust
Oxford England, OX3 7, United Kingdom
Oxford England, OX3 7, United Kingdom
Southampton General Hospital
Southampton England, SO16 , United Kingdom
Southampton England, SO16 , United Kingdom
Mount Vernon Hospital
Middlesex , HA6 2, United Kingdom
Middlesex , HA6 2, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom
Wolverhampton , WV10 , United Kingdom
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