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A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug when combined with chemotherapy * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality of life and ability to complete routine daily activities
Official title: A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
904
Start Date
2023-12-13
Completion Date
2029-09-12
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Odronextamab
Odronextamab will be administered by intravenous (IV) infusion
Rituximab
Rituximab will be administered IV, or subcutaneously (SC)
Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Vincristine
Vincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Locations (194)
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Landeskrankenhaus Hochsteiermark
Leoben, Styria, Austria
Kepler University Hospital
Linz, Upper Austria, Austria
Medical University Graz
Graz, Austria
Medical University of Vienna
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium
Centre Hospitalier Regional de Verviers
Verviers, Liege, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium
Institut Jules Bordet
Brussels, Belgium
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil
Instituto Mario Penna de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais, Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Instituto Tacchini de Pesquisa em Saude
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e Oncologia
Joinville, Santa Catarina, Brazil
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Amor
Barretos, São Paulo, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil
Instituto Americas
Rio de Janeiro, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
AC Camargo Cancer Center
São Paulo, Brazil
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, Brazil
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile
Inmunocel
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de Santiago
Santiago, Chile
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia
University Hospital Brno
Brno, South Moravian, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Centre Hospitalier de Cornouaille Quimper Concarneau
Quimper, Brittany Region, France
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, France
CHRU de Tours
Tours, Centre-Val de Loire, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, New Aquitaine, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine, France
Hopital Saint Vincent-de-Paul
Lille, Nord, France
Nantes University Hospital
Nantes, Pays de la Loire Region, France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France
Centre Hospitalier Universitaire Angers
Angers, France
Centre Leon Berard
Lyon, France
Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
Marseille, France
Change Annecy
Metz-Tessy, France
CHU Nimes Institut de Cancerologie
Nîmes, France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France
CHU de Saint-Etienne
Saint-Etienne, France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France
Avicenne Hospital
Bobigny, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany
UKS Homburg
Homburg, Saarland, Germany
Hematological Praxis Dresden
Dresden, Saxony, Germany
Vivantes Klinikum Am Urban
Berlin, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Stadtisches Krankenhaus Kiel
Kiel, Germany
Beaumont Hospital
Dublin, Leinster, Ireland
St James Hospital and Trinity College Dublin
Dublin, Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv, Israel
Samson Assuta Ashdod University Hospital
Ashdod, Israel
Bnai Zion Medical Center
Haifa, Israel