GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00576758

Run by

Hoffmann-La Roche

People needed

175

Starts

2008-01-01

Expected to finish

2013-03-01

Last updated by the study team

2014-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Cumberland, Maryland, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Concord, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Innsbruck, Austria
• Study site — Salzburg, Austria
• Study site — Vienna, Austria
• Study site — Brussels, Belgium
• Study site — Ghent, Belgium
• Study site — Mont-godinne, Belgium
• Study site — Goiânia, Goiás, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — Piracicaba, São Paulo, Brazil
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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