Clinical trial NCT01059630: 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)
Official title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: follicular
follicular lymphoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roche Pharma AG
First posted: 2010-02-01
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).


Eligibility criteria: Inclusion Criteria:

* History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
* 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:

* Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
* 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

Primary outcomes:
measure: Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death
timeFrame: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
measure: Progression-Free Survival (PFS) as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
Secondary outcomes:
measure: Number of Participants With PD or Death as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to 8.5 years overall))
measure: PFS as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to 8.5 years overall)
measure: Percentage of Participants With Objective Response as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
measure: Percentage of Participants With Objective Response as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
measure: Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
measure: Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
measure: Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC
timeFrame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
measure: Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator
timeFrame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
measure: Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC
timeFrame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
measure: Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator
timeFrame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
measure: Duration of Response (DoR) as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
measure: Duration of Response (DoR) as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
measure: Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
measure: Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
measure: Event-free Survival (EFS) as Assessed by IRC
timeFrame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
measure: Percentage of Participants Who Died
timeFrame: Baseline until death (up to 8.5 years overall)
measure: Overall Survival (OS)
timeFrame: Baseline until death (up to 8.5 years overall)
measure: Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym-Social/Family Well-being Sub-scale Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym-Emotional Well-Being Sub-scale Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym-Functional Well-Being Sub-scale Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym-Lymphoma Sub-scale Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
measure: CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase
timeFrame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)
measure: CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
measure: CFB in EQ-5D VAS Score During Maintenance Phase
timeFrame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)
measure: CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym Trial Outcome Index (TOI)
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: CFB in FACT-Lym Total Score
timeFrame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
measure: Time to Deterioration of FACT-Lym TOI
timeFrame: Baseline up to approximately 8.5 years
measure: Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores
timeFrame: Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Casa Grande
country: United States
facility: Dr. Donald W. Hill, MD, FACP
state: Arizona
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Bellflower
country: United States
facility: Kaiser Permanente - Bellflower
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Washington DC VA Med Center; Hematology
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida; Division of Hematology/Oncology
state: Florida
city: Orlando
country: United States
facility: Md Anderson Cancer Center Orlando
state: Florida
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Springfield
country: United States
facility: Simmons Cancer Institute
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Univ Louisville School of Med
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Jefferson City
country: United States
facility: Capitol Comprehensive CA Care
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology Oncology Assoc SJ
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology
state: New Mexico
city: Columbus
country: United States
facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
state: Ohio
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Pacific Oncology, PC
state: Oregon
city: Portland
country: United States
facility: OHSU Ctr for Health & Healing
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health System
state: South Dakota
city: Corpus Christi
country: United States
facility: South Texas Inst of Cancer
state: Texas
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Madison
country: United States
facility: Univ of Wisconsin Hosp & Clin
state: Wisconsin
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Cancer Care
state: Manitoba
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: East York
country: Canada
facility: Toronto East General Hospital; Main Pharmacy G Wing Basement
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM-Hosp Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: CHA Hopital de I enfant-Jesus
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Prague 2
country: Czechia
facility: I Interni klinika; Vseobecna fakultni nemocnice
city: Bordeaux
country: France
facility: Institut Bergonie; Hematologie Oncologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CH Dijon
city: LeMans
country: France
facility: Centre d'oncologie-radiotherap
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lyon
country: France
facility: Centre Leon Berard
city: Metz
country: France
facility: Hopital Bon Secour
city: Montpellier
country: France
facility: CHU Hopital Saint Eloi
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Hopital Saint Louis; Dermatologie 1
city: Pessac
country: France
facility: CHU Bordeaux
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud; Hematolgie
city: Poitiers
country: France
facility: Chu De Poitiers; Chu La Miletrie
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Strasbourg
country: France
facility: Clinique Ste Anne
city: Vandoeuvre
country: France
facility: CHRU de; Maladies, Vasculaires
city: Duisburg
country: Germany
facility: St. Johannes Hospital Duisburg
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: München
country: Germany
facility: Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum GmbH
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria di Modena
state: Emilia-Romagna
city: Udine
country: Italy
facility: Azienda Ospedaliera Univ, Ematologica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera Univ
state: Lazio
city: Roma
country: Italy
facility: Universita La Sapienza
state: Lazio
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Pavia
country: Italy
facility: Irccs Policlinico San Matteo; Divisione Di Ematologia
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedale San Giovanni
state: Piemonte
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
state: Piemonte
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: Puglia
city: Catania
country: Italy
facility: Azienda Ospedaliero Univ
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Univ
state: Toscana
city: Amsterdam
country: Netherlands
facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Hospital
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
city: Moscow
country: Russian Federation
facility: City Clin Hosp n.a. S.P.Botkin
city: Moscow
country: Russian Federation
facility: Russian Hema Res Ctr of RAMS
city: Petrozavodsk
country: Russian Federation
facility: Republican Clinical Hospital n.a. Baranov; Haematology
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hosp
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
city: St. Petersburg
country: Russian Federation
facility: SRI of Hematology and Transfusiology
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Sevillac
country: Spain
facility: Hospital Univ. Nuestra Señora de Valme;
state: Sevilla
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: Vizcaya
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Lund
country: Sweden
facility: Skånes University Hospital, Skånes Department of Onclology
city: Stockholm
country: Sweden
facility: Hematology Center; Karolinska Univ Hosp
city: Umeå
country: Sweden
facility: Norrlands Uni Hospital; Onkologi Avd.
city: Uppsala
country: Sweden
facility: Onc Clin, Akademiska Sjukhuset
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: Bern
country: Switzerland
facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Barts & London School of Med; Medical Oncology
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy Department
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.