Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
- Conditions
- Indolent Non-Hodgkin's Lymphomas
- Interventions
- Registration Number
- NCT01732926
- Lead Sponsor
- Gilead Sciences
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 475
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab + Bendamustine + Idelalisib Idelalisib Participants will receive rituximab + bendamustine + idelalisib. Rituximab + Bendamustine + Idelalisib Rituximab Participants will receive rituximab + bendamustine + idelalisib. Rituximab + Bendamustine + Idelalisib Bendamustine Participants will receive rituximab + bendamustine + idelalisib. Rituximab + Bendamustine + Placebo Rituximab Participants will receive rituximab + bendamustine + placebo. Rituximab + Bendamustine + Placebo Placebo Participants will receive rituximab + bendamustine + placebo. Rituximab + Bendamustine + Placebo Bendamustine Participants will receive rituximab + bendamustine + placebo.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Lymph Node Response Rate Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Overall Survival (OS) Overall survival is defined as the interval from randomization to death from any cause.
Complete Response Rate (CR) Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
Trial Locations
- Locations (141)
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
Spedali Civili Di Brescia Azienda Ospedaliera
🇮🇹Brescia, Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
🇮🇹Novara, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
🇮🇹Siena, Italy
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
🇷🇺Volgograd, Russian Federation
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
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
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
Joliet Oncology Hematology Associates Ltd.
🇺🇸Joliet, Illinois, 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
Texas Oncology, P.A.
🇺🇸Weslaco, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Northwest Medical Specialists
🇺🇸Tacoma, Washington, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Haematology and Oncology Clinics of Australia Gold Coast
🇦🇺South Brisbane, Queensland, 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
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
Hôpital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, 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
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 Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, Rhone-alpes, France
Centre Hospitalier Universitaire Brest
🇫🇷Brest Cedex, 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
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano, Italy
Hadassah Medical Organization, Ein Kerem
🇮🇱Jerusalem, Israel
IRCCS Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Ospedale San Raffaele-IRCCS
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, 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
Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
🇵🇱Lublin, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
🇵🇱Slupsk, Poland
Sverdlovsk Regional Clinical Hospital #1
🇷🇺Ekaterinburg, Russian Federation
Central City Hospital # 7
🇷🇺Ekaterinburg, Russian Federation
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Karolinska Universitetssjukhuset
🇸🇪Huddinge, Stockholm, Sweden
Hospital Universitari i Politecnic La Fé de Valencia
🇪🇸Valencia, Spain
Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng-Kung University Hospital
🇨🇳Tainan, Taiwan
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
University Hospital Coventry
🇬🇧Coventry, England, United Kingdom
Royal Bournemouth General Hospital
🇬🇧Dorset, England, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, England, United Kingdom
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Centre Jean Bernard
🇫🇷Le Mans, PAYS DE LA Loire, France
Centre Hospitalier de Dunkerque
🇫🇷Dunkerque, France
Western Hospital
🇦🇺Footscray, Victoria, Australia
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
🇵🇱Lódz, Poland
Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
🇨🇦Halifax, Nova Scotia, Canada
Rambam Health Corp.
🇮🇱Haifa, Israel
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Bon Secours Saint Francis Hospital
🇺🇸Greenville, South Carolina, United States
Fraser Clinical Trials, Inc.
🇨🇦New Westminster, British Columbia, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
🇫🇷Strasbourg Cedex, Alsace, France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
🇵🇱Olsztyn, Poland
Ryazan Regional Clinical Hospital
🇷🇺Ryazan, Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology
🇷🇺Saint Petersburg, Russian Federation
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
CHR Metz
🇫🇷Metz Cedex 03, Alsace, France
Saint Petersburg I.P. Pavlov State Medical University
🇷🇺Saint-Petersburg, Russian Federation
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱Warszawa, Poland
Instytut Hematologii i Transfuzjologii
🇵🇱Warszawa, Poland
N. N. Blokhin Russian Cancer Research Center
🇷🇺Moscow, Russian Federation
Malopolskie Centrum Medyczne S.C.
🇵🇱Kraków, Poland
Centrum Onkologii i Hipertermii
🇵🇱Warszawa, Poland
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Saratov State Medical University
🇷🇺Saratov, Russian Federation
Changhua Christian Hospital
🇨🇳Changhua city, Taiwan
Guys and Saint Thomas NHS Foundation Trust
🇬🇧London, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Oxford University Hospitals NHS Trust
🇬🇧Oxford, 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
Klinikum der Ludwig-Maximilians-Universität München
🇩🇪München, Germany
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Hospital Universitario de Canarias
🇪🇸San Cristobal de La Laguna, Spain
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Comprehensive Blood and Cancer Center (Bakersfield)
🇺🇸Bakersfield, California, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
St Joseph Heritage Healthcare System
🇺🇸Santa Rosa, California, United States
Central Coast Medical Oncology Group
🇺🇸Santa Maria, California, United States