GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma
An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma
1 other identifier
interventional
175
17 countries
71
Brief Summary
This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
Longer than P75 for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2007
CompletedFirst Posted
Study publicly available on registry
December 19, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
March 31, 2014
CompletedAugust 19, 2014
August 1, 2014
3.7 years
December 18, 2007
November 27, 2013
August 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Overall Response At the End of Induction Period
Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.
Randomization to clinical cutoff: 01 September 2011 (Up to 70 days)
Secondary Outcomes (23)
Percentage of Participants With Complete Response at the End of the Induction Period
Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)
Percentage of Participants With Partial Response (PR) at the End of the Induction Period
Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)
Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment
Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)
Number of Participants With Improved Overall Response During the Extended Treatment Period
Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)
Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment
Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)
- +18 more secondary outcomes
Study Arms (2)
Obinutuzumab
EXPERIMENTALParticipants 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.
Rituximab
ACTIVE COMPARATORParticipants 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.
Interventions
1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age
- 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
You may not qualify if:
- prior use of any investigational monoclonal antibody within 6 months of study start
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Unknown Facility
Los Angeles, California, 90024, United States
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Denver, Colorado, 80220, United States
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Gainesville, Florida, 32610, United States
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Tampa, Florida, 33612, United States
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Augusta, Georgia, 30912, United States
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Cumberland, Maryland, 21502, United States
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Hackensack, New Jersey, 07601, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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Concord, North Carolina, 28025, United States
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Columbus, Ohio, 43219, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98109, United States
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Buenos Aires, 1406, Argentina
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Buenos Aires, C1221ADC, Argentina
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Buenos Aires, C1431FWO, Argentina
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Mont-godinne, 5530, Belgium
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Goiânia, Goiás, 74140-050, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Piracicaba, São Paulo, 13419-155, Brazil
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São Paulo, São Paulo, 01323-020, Brazil
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São Paulo, São Paulo, 04029-000, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Rijeka, 51000, Croatia
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Zagreb, 10000, Croatia
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Aarhus, 8000, Denmark
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Copenhagen, 2100, Denmark
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Vejle, 7100, Denmark
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Athens, 115 27, Greece
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Thessaloniki, 570 10, Greece
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Milan, 20141, Italy
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Milan, 20162, Italy
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Novara, 28100, Italy
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Pisa, 56100, Italy
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Reggio Calabria, 89100, Italy
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Rozzano, 20089, Italy
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Amsterdam, 1105 AZ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Rotterdam, 3075EA, Netherlands
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Warsaw, 02-097, Poland
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Warsaw, 02-781, Poland
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08035, Spain
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A Coruña, La Coruña, 15006, Spain
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Madrid, Madrid, 28046, Spain
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Salamanca, Salamanca, 37007, Spain
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Seville, Sevilla, 41013, Spain
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Valencia, Valencia, 46010, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Huddinge, 14186, Sweden
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Malmo, 205 02, Sweden
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Istanbul, 34365, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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London, N6A 4L6, United Kingdom
Related Publications (4)
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.
PMID: 31050355DERIVEDKostakoglu 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.
PMID: 27339738DERIVEDSehn 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.
PMID: 26282650DERIVEDSehn 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.
PMID: 22438256DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2007
First Posted
December 19, 2007
Study Start
January 1, 2008
Primary Completion
September 1, 2011
Study Completion
March 1, 2013
Last Updated
August 19, 2014
Results First Posted
March 31, 2014
Record last verified: 2014-08