A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
NCT ID: NCT01059630
Last Updated: 2020-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
413 participants
INTERVENTIONAL
2010-04-30
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bendamustine Alone
Participants will receive bendamustine 120 milligrams per meter square (mg/m\^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Bendamustine
IV infusion.
Obinutuzumab + Bendamustine
Induction phase: Participants will receive bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants will also receive obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.
Maintenance phase: Participants with complete response (CR), partial response (PR) or stable response (SD) then will receive obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurs first).
Obinutuzumab
IV infusion.
Bendamustine
IV infusion.
Interventions
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Obinutuzumab
IV infusion.
Bendamustine
IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen)
* Previously treated with a maximum of four unique chemotherapy containing treatment regimens
* All participants must have at least one bi-dimensionally measurable lesion (greater than \[\>\]1.5 centimeters (cm) in its largest dimension by computed tomography \[CT\] scan)
Exclusion Criteria
* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
* Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* History of sensitivity to mannitol
* Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
* Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
* Vaccination with a live vaccine a minimum of 28 days prior to randomization
* Recent major surgery (within 4 weeks), other than for diagnosis
* Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen \[anti-HBc\]) with detectable viral load (positive hepatitis B virus \[HBV\] deoxyribo-nucleic acid \[DNA\]) or Hepatitis C
* Participants with chronic hepatitis B or seropositive occult (HBV) infection
* Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
* Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
* Known history of human immunodeficiency virus (HIV) seropositive status
* Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
* Women who are pregnant or lactating
* Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
* Ongoing corticosteroid use \>30 milligrams per day (mg/day) prednisone or equivalent
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Southern Cancer Center, PC
Mobile, Alabama, United States
Dr. Donald W. Hill, MD, FACP
Casa Grande, Arizona, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Kaiser Permanente - Bellflower
Bellflower, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Washington DC VA Med Center; Hematology
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Florida; Division of Hematology/Oncology
Gainesville, Florida, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, United States
Rush Cancer Institute
Chicago, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Simmons Cancer Institute
Springfield, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Univ Louisville School of Med
Louisville, Kentucky, United States
New England Cancer Specialists
Scarborough, Maine, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Capitol Comprehensive CA Care
Jefferson City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Hematology Oncology Assoc SJ
Mount Holly, New Jersey, United States
San Juan Oncology
Farmington, New Mexico, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
Columbus, Ohio, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Pacific Oncology, PC
Portland, Oregon, United States
OHSU Ctr for Health & Healing
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Sanford Health System
Sioux Falls, South Dakota, United States
South Texas Inst of Cancer
Corpus Christi, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Univ of Wisconsin Hosp & Clin
Madison, Wisconsin, United States
Lkh-Univ. Klinikum Graz
Graz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
ZNA Stuivenberg
Antwerp, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU Ambroise Paré
Mons, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Manitoba Cancer Care
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Toronto East General Hospital; Main Pharmacy G Wing Basement
East York, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM-Hosp Notre Dame
Montreal, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
CHA Hopital de I enfant-Jesus
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
I Interni klinika; Vseobecna fakultni nemocnice
Prague, , Czechia
Institut Bergonie; Hematologie Oncologie
Bordeaux, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
Hopital Henri Mondor
Créteil, , France
CH Dijon
Dijon, , France
Centre d'oncologie-radiotherap
LeMans, , France
Hopital Claude Huriez
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Bon Secour
Metz, , France
CHU Hopital Saint Eloi
Montpellier, , France
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, , France
Hopital Necker
Paris, , France
Hopital Saint Louis; Dermatologie 1
Paris, , France
CHU Bordeaux
Pessac, , France
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite, , France
Chu De Poitiers; Chu La Miletrie
Poitiers, , France
CHU de Reims
Reims, , France
Hopital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Clinique Ste Anne
Strasbourg, , France
CHRU de; Maladies, Vasculaires
Vandœuvre-lès-Nancy, , France
St. Johannes Hospital Duisburg
Duisburg, , Germany
Klinikum Frankfurt Höchst
Frankfurt am Main, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III
München, , Germany
Schwarzwald-Baar Klinikum GmbH
Villingen-Schwenningen, , Germany
Ospedale Vito Fazzi
Lecce, Apulia, Italy
Azienda Ospedaliera Universitaria di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera Univ, Ematologica
Udine, Friuli Venezia Giulia, Italy
Azienda Ospedaliera Univ
Rome, Lazio, Italy
Universita La Sapienza
Rome, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, Italy
Azienda Ospedale San Giovanni
Turin, Piedmont, Italy
Ospedale Mauriziano Umberto I
Turin, Piedmont, Italy
Azienda Ospedaliero Univ
Catania, Sicily, Italy
Azienda Ospedaliera Univ
Florence, Tuscany, Italy
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Rotterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
Regional Oncology Hospital
Irkutsk, , Russia
Blokhin Cancer Research Center; Combined Treatment
Moscow, , Russia
City Clin Hosp n.a. S.P.Botkin
Moscow, , Russia
Russian Hema Res Ctr of RAMS
Moscow, , Russia
Republican Clinical Hospital n.a. Baranov; Haematology
Petrozavodsk, , Russia
Ryazan Regional Clinical Hosp
Ryazan, , Russia
SRI of Hematology and Transfusiology
Saint Petersburg, , Russia
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint Petersburg, , Russia
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Univ. Nuestra Señora de Valme;
Sevillac, Sevilla, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario de la Princesa; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Skånes University Hospital, Skånes Department of Onclology
Lund, , Sweden
Hematology Center; Karolinska Univ Hosp
Stockholm, , Sweden
Norrlands Uni Hospital; Onkologi Avd.
Umeå, , Sweden
Onc Clin, Akademiska Sjukhuset
Uppsala, , Sweden
Universitaetsspital Basel; Onkologie
Basel, , Switzerland
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, , Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, , Switzerland
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts & London School of Med; Medical Oncology
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Singleton Hospital; Pharmacy Department
Swansea, , United Kingdom
Countries
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References
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Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.
Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.
Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.
Sehn LH, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.
Other Identifiers
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GO01297
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015504-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GAO4753g
Identifier Type: -
Identifier Source: org_study_id
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