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A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
Official title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2021-02-23
Completion Date
2028-03-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
Glofitamab
Participants will receive IV glofitamab for up to 12 cycles.
Rituxumab
Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
Tocilizumab
Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
Gemcitabine
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Oxaliplatin
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Locations (63)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Community Cancer Institute (CCI)
Fresno, California, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
UZ Leuven Gasthuisberg
Leuven, Belgium
CHU de Liège (Sart Tilman)
Liège, Belgium
Peking University Third Hospital
Beijing, China
Sun Yet-sen University Cancer Center
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin Cancer Hospital
Tianjin, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhejiang Cancer Hospital
Zhejiang, China
Henan Cancer Hospital
Zhengzhou, China
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Rigshospitalet
København Ø, Denmark
Institut Bergonie
Bordeaux, France
Hopital Henri Mondor
Créteil, France
Hopital Claude Huriez
Lille, France
Chu de Montpellier-St Eloi
Montpellier, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU Pontchaillou
Rennes, France
Universitatsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I
Giessen, Germany
Universitaetsklinikum Regensburg
Regensburg, Germany
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
Lublin, Poland
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, Poland
Pusan National University Hospital
Busan, South Korea
National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic i Provincial
Barcelona, Spain
Hospital Universitario la Paz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Inselspital Bern, Insel-Gruppe AG
Bern, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Chang Gung Medical Foundation - Kaohsiung;Oncology
Kaoisung, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, Taiwan
Taichung Veterans General Hospital
Xitun Dist., Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James's Institute of Oncology
Leeds, United Kingdom
UCLH - Clinical Trials Pharmacy B&D Centre
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom