Trials / Completed
CompletedNCT00576758
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | obinutuzumab (RO5072759) | 1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks. |
| DRUG | rituximab | 375 mg/m\^2 rituximab IV infusion once a week for 4 weeks. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2011-09-01
- Completion
- 2013-03-01
- First posted
- 2007-12-19
- Last updated
- 2014-08-19
- Results posted
- 2014-03-31
Locations
71 sites across 17 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Greece, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00576758. Inclusion in this directory is not an endorsement.