GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma
NCT ID: NCT00576758
Last Updated: 2014-08-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2008-01-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
NCT03075696
A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma
NCT06561425
Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
NCT00179673
A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
NCT02417285
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
NCT00413036
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Obinutuzumab
Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
obinutuzumab (RO5072759)
1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
Rituximab
Participants received 375 mg/m\^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m\^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
rituximab
375 mg/m\^2 rituximab IV infusion once a week for 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
obinutuzumab (RO5072759)
1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
rituximab
375 mg/m\^2 rituximab IV infusion once a week for 4 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
* documented history of response of \>/= 6 months duration from last rituximab-containing regimen
* clinical indication for treatment as determined by the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
* prior use of any anti-cancer vaccine
* prior use of rituximab within 8 weeks of study entry
* radioimmunotherapy within 3 months prior to study entry
* Central Nervous System (CNS) lymphoma or evidence of transformation to high-grade or diffuse large B-cell lymphoma
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Cumberland, Maryland, United States
Hackensack, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Concord, North Carolina, United States
Columbus, Ohio, United States
Houston, Texas, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Brussels, , Belgium
Ghent, , Belgium
Mont-godinne, , Belgium
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Piracicaba, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Rijeka, , Croatia
Zagreb, , Croatia
Aarhus, , Denmark
Copenhagen, , Denmark
Vejle, , Denmark
Athens, , Greece
Thessaloniki, , Greece
Bologna, , Italy
Brescia, , Italy
Milan, , Italy
Milan, , Italy
Novara, , Italy
Pisa, , Italy
Reggio Calabria, , Italy
Rozzano, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Warsaw, , Poland
Warsaw, , Poland
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
A Coruña, La Coruña, Spain
Madrid, Madrid, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Huddinge, , Sweden
Malmo, , Sweden
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kostakoglu L, Goy A, Martinelli G, Caballero D, Crump M, Gaidano G, Baetz T, Buckstein R, Fine G, Fingerle-Rowson G, Berge C, Sahin D, Press O, Sehn L. FDG-PET is prognostic and predictive for progression-free survival in relapsed follicular lymphoma: exploratory analysis of the GAUSS study. Leuk Lymphoma. 2017 Feb;58(2):372-381. doi: 10.1080/10428194.2016.1196815. Epub 2016 Jun 24.
Sehn LH, Goy A, Offner FC, Martinelli G, Caballero MD, Gadeberg O, Baetz T, Zelenetz AD, Gaidano G, Fayad LE, Buckstein R, Friedberg JW, Crump M, Jaksic B, Zinzani PL, Padmanabhan Iyer S, Sahin D, Chai A, Fingerle-Rowson G, Press OW. Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study. J Clin Oncol. 2015 Oct 20;33(30):3467-74. doi: 10.1200/JCO.2014.59.2139. Epub 2015 Aug 17.
Sehn LH, Assouline SE, Stewart DA, Mangel J, Gascoyne RD, Fine G, Frances-Lasserre S, Carlile DJ, Crump M. A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood. 2012 May 31;119(22):5118-25. doi: 10.1182/blood-2012-02-408773. Epub 2012 Mar 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BO21003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.