Non Hodgkin Lymphoma Clinical Trial
GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin’s Lymphoma
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.
Eligibility 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
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There are 71 Locations for this study
Los angeles California, 90024, United States
Denver Colorado, 80220, United States
Gainesville Florida, 32610, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Cumberland Maryland, 21502, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Concord North Carolina, 28025, United States
Columbus Ohio, 43219, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Buenos Aires , 1406, Argentina
Buenos Aires , C1221, Argentina
Buenos Aires , C1431, Argentina
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Mont-godinne , 5530, Belgium
Goiania GO, 74140, Brazil
Porto Alegre RS, 90035, Brazil
Piracicaba SP, 13419, Brazil
Sao Paulo SP, 01323, Brazil
Sao Paulo SP, 04029, Brazil
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Kingston Ontario, K7L 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3A 1, Canada
Montreal Quebec, H3T 1, Canada
Rijeka , 51000, Croatia
Zagreb , 10000, Croatia
København , 2100, Denmark
Vejle , 7100, Denmark
Ã…rhus , 8000, Denmark
Athens , 115 2, Greece
Thessaloniki , 570 1, Greece
Bologna , 40138, Italy
Brescia , 25123, Italy
Milano , 20141, Italy
Milano , 20162, Italy
Novara , 28100, Italy
Pisa , 56100, Italy
Reggio Calabria , 89100, Italy
Rozzano , 20089, Italy
Amsterdam , 1105 , Netherlands
Groningen , 9713 , Netherlands
Rotterdam , 3015 , Netherlands
Rotterdam , 3075E, Netherlands
Warszawa , 02-09, Poland
Warszawa , 02-78, Poland
Palma de Mallorca Islas Baleares, 07198, Spain
La Coruna La Coruña, 15006, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Madrid , 28046, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Huddinge , 14186, Sweden
Malmo , 205 0, Sweden
St. Gallen , 9007, Switzerland
Zürich , 8091, Switzerland
Istanbul , 34365, Turkey
Izmir , 35100, Turkey
London , N6A 4, United Kingdom
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