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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: obinutuzumab (RO5072759); Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576758

BO21003

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Obinutuzumab

Experimental group

Description:

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.

Treatment:

Drug: obinutuzumab (RO5072759)

Rituximab

Active Comparator group

Description:

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.

Treatment:

Drug: rituximab