Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04408638
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Obinutuzumab

Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.

DRUG

Glofitamab

Participants will receive IV glofitamab for up to 12 cycles.

DRUG

Rituxumab

Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).

DRUG

Gemcitabine

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

DRUG

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