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Brief Title: 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
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
Study ID: NCT04408638
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Community Cancer Institute (CCI), Fresno, California, United States
Baptist Medical Center - Jacksonville, Jacksonville, Florida, 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; Haematology, Randwick, New South Wales, Australia
Royal Adelaide Hospital; Haematology Clinical Trials, 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 Sart-Tilman, Liège, , Belgium
Peking University Third Hospital, Beijing, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Tianjin Cancer Hospital, Tianjin, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan City, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Henan Cancer Hospital, Zhengzhou, , China
Aarhus Universitetshospital Skejby; Blodsygdomme, Aarhus N, , Denmark
Rigshospitalet; Hæmatologisk Klinik, København Ø, , Denmark
Institut Bergonie; Hematologie Oncologie, Bordeaux, , France
Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny, Creteil, , France
Hopital Claude Huriez; Hematologie, Lille, , France
CHU DE MONTPELLIER-ST ELOI; Département d'Hématologie Clinique, Montpellier, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU Pontchaillou; Service Hématologie, Rennes, , France
Universitatsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I, Giessen, , Germany
Universitaetsklinikum Regensburg, Regensburg, , Germany
Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin, Stuttgart, , Germany
Pusan National University Hospital, Busan, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
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
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku, Pozna?, , Poland
Instytut Hematologii i Transfuzjologii; Klinika Hematologii, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroc?aw, , Poland
PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center, San Juan, , Puerto Rico
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia, Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital Universitario la Paz; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Inselspital Bern, Insel-Gruppe AG, Bern, , Switzerland
Universitätsspital Zürich, Zürich, , Switzerland
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology, Kaoisung, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan, , Taiwan
Taichung Veterans General Hospital, Xitun Dist., , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St James's Institute of Oncology; Dept of Haematology, Leeds, , United Kingdom
UCLH - Clinical Trials Pharmacy B&D Centre, London, , United Kingdom
Christie Hospital; Department of Haematology and Transplant, Manchester, , United Kingdom
Nottingham City Hospital; Dept of Haematology, Nottingham, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR