Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Bridalveil
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
2 other identifiers
interventional
475
15 countries
144
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2013
Typical duration for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 26, 2012
CompletedStudy Start
First participant enrolled
January 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2016
CompletedResults Posted
Study results publicly available
May 11, 2017
CompletedNovember 16, 2018
March 1, 2017
3.4 years
November 14, 2012
March 30, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Complete Response Rate (CR)
Overall Response Rate (ORR)
Lymph Node Response Rate
Overall Survival (OS)
Study Arms (2)
Rituximab + Bendamustine + Idelalisib
EXPERIMENTALParticipants will receive rituximab + bendamustine + idelalisib.
Rituximab + Bendamustine + Placebo
EXPERIMENTALParticipants will receive rituximab + bendamustine + placebo.
Interventions
150 mg tablet administered orally twice daily
375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (144)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
Comprehensive Blood and Cancer Center (Bakersfield)
Bakersfield, California, 93309, United States
Saint Jude Heritage Healthcare (TORI)
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Cancer Care Associates
Redondo Beach, California, 90277, United States
San Luis Obispo Oncology and Hematology
San Luis Obispo, California, 93401, United States
Cancer Center of Santa Barbara
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Group
Santa Maria, California, 93454, United States
St Joseph Heritage Healthcare System
Santa Rosa, California, 95403, United States
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589, United States
Sylvester Comprehensive Cancer Center/UMHC
Deerfield Beach, Florida, 33442, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Joliet Oncology Hematology Associates Ltd.
Joliet, Illinois, 60435, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
North Shore Hematology/Oncology Associates
East Setauket, New York, 11733, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Bon Secours Saint Francis Hospital
Greenville, South Carolina, 29607, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology, P.A.
Denton, Texas, 76210, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Texas Oncology, P.A.
Harlingen, Texas, 78550-8321, United States
Texas Oncology, P.A.
Weslaco, Texas, 78596-6608, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Northwest Medical Specialists
Tacoma, Washington, 98405, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54308, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Haematology and Oncology Clinics of Australia Gold Coast
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Saint Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Tom Baker Cancer Center
Calgary, Alberta, T2N 2T9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Fraser Clinical Trials, Inc.
New Westminster, British Columbia, V3L 3W4, Canada
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V7, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Hôpital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3JI, Canada
Centre Hospitalier Affilie Universitaire de Quebec
Québec, Quebec, G1J 1Z4, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
CancerCare Manitoba
Winnipeg, R3E 0V9, Canada
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky KRAJ, 708 52, Czechia
Fakultní nemocnice Brno
Brno, 625 00, Czechia
Fakultní nemocnice Hradec Králové
Hradec Králové, 500 05, Czechia
CHR Metz
Metz, Alsace, 57085, France
Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
Strasbourg, Alsace, 67098, France
Institut Bergonié
Bordeaux, Aquitaine, 33076, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Centre Henri-Becquerel
Rouen, Haute-normandie, 76038, France
Centre Jean Bernard
Le Mans, Pays de la Loire Region, 72000, France
Centre Hospitalier Universitaire Brest
Brest, 29609, France
Centre Hospitalier de Dunkerque
Dunkirk, 59385, France
Centre Hospitalier Départmental La Roche sur Yon
La Roche-sur-Yon, 85925, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
Hôpital Hôtel-Dieu
Nantes, 44093, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
Tours, 37044, France
Institut Gustave Roussy
Villejuif, 94805, France
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, 75015, France
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany
Gemeinschaftspraxis Dres. Söling Und Siehl
Kassel, Hesse, 34117, Germany
Vivantes Klinikum am Urban
Berlin, 10967, Germany
Charite - Campus Virchow
Berlin, 13353, Germany
Klinikum der Ludwig-Maximilians-Universität München
München, 81377, Germany
Barzilai Medical Center
Ashkelon, 78278, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Health Corp.
Haifa, 31096, Israel
Hadassah Medical Organization, Ein Kerem
Jerusalem, 91120, Israel
Centro di Riferimento Oncologico di Aviano
Aviano, 33081, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia, 25123, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Ospedale San Raffaele-IRCCS
Milan, 20132, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
Novara, 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, 61122, Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, 29100, Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, 53100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
Lódz, 93-510, Poland
Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, 20-081, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn, 10-228, Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Słupsk, 76-200, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Centrum Onkologii i Hipertermii
Warsaw, 02-781, Poland
N. N. Blokhin Russian Cancer Research Center
Moscow, 115478, Russia
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126, Russia
Ryazan Regional Clinical Hospital
Ryazan, 390039, Russia
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
Saint Petersburg I.P. Pavlov State Medical University
Saint Petersburg, 197022, Russia
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
Saint Petersburg, 197341, Russia
Saratov State Medical University
Saratov, 140012, Russia
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
Volgograd, 400138, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102, Russia
Central City Hospital # 7
Yekaterinburg, 620137, Russia
Dong-A University Medical Center
Busan, 602-715, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, 46026, Spain
Karolinska Universitetssjukhuset
Huddinge, Stockholm County, 141 86, Sweden
Länssjukhuset Ryhov
Jönköping, 551 85, Sweden
Changhua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
National Cheng-Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG, United Kingdom
University Hospital Coventry
Coventry, England, CV2 2DX, United Kingdom
Royal Bournemouth General Hospital
Dorset, England, BH7 7DW, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, England, LS9 7TF, United Kingdom
Barts and The London NHS Trust
London, England, EC1M 6BQ, United Kingdom
University College London Hospitals National Health Society Foundation Trust
London, England, NW1 2PG, United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London, England, SE1 9RT, United Kingdom
Imperial College Healthcare NHS Trust
London, England, W12 0NN, United Kingdom
Maidstone Hospital
Maidstone, England, ME16 9QQ, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, England, M20 4BX, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, England, OX3 7LE, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Mount Vernon Hospital
Middlesex, HA6 2RN, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 26, 2012
Study Start
January 2, 2013
Primary Completion
May 17, 2016
Study Completion
May 17, 2016
Last Updated
November 16, 2018
Results First Posted
May 11, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.