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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Obinutuzumab; Rituximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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