RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06091865

Registry updated: 2026-10-07

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Description

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

Interventions

Odronextamab (Drug)
Odronextamab will be administered by intravenous (IV) infusion
Rituximab (Drug)
Rituximab will be administered IV, or subcutaneously (SC)
Cyclophosphamide (Drug)
Cyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin (Drug)
Doxorubicin will be administered IV as part of chemotherapy
Vincristine (Drug)
Vincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone (Drug)
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Eligibility criteria

Key Inclusion Criteria: 1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only 6. Adequate hematologic and organ function, as defined in the protocol. Key Exclusion Criteria: 1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology 2. Another active malignancy, significant active disease or medical condition, as described in the protocol 3. Peripheral neuropathy Grade ≥3 4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment 6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol 7. Allergy/hypersensitivity to study drugs, as described in the protocol 8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Locations

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
Hadassah Medical Center — Jerusalem, Israel
Galilee Medical Center — Nahariya, Israel
The Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Forli-Cesena, Italy
ASST Monza Ospedale San Gerardo — Monza, Monza E Brianza, Italy
Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin — Turin, Piedmont, Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address — Milan, Italy
Istituto Europeo di Oncologia — Milan, Italy
A.O.U. di Modena — Modena, Italy
Federico II University — Naples, Italy
AOU Maggiore della Carita — Novara, Italy
Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
Azienda Ospedaliera di Perugia — Perugia, Italy
Ospedale Santa Maria delle Croci — Ravenna, Italy
Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Italy
Hematology - Città della Salute e della Scienza di Torino — Turin, Italy
Santa Maria della Misericordia — Udine, Italy
Ospedale di Circolo e Fondazione Macchi Varese — Varese, Italy
University Malaya Medical Centre — Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tg Ampuan Afzan — Kuantan, Pahang, Malaysia
Hospital Queen Elizabeth — Kota Kinabalu, Sabah, Malaysia
Hospital Ampang — Ampang, Selangor, Malaysia
Subang Jaya Medical Center — Subang Jaya, Selangor, Malaysia
Matopolskie Centrum Medyczne S.C. — Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny — Wroclaw, Lower Silesian Voivodeship, Poland
Pratia Poznan Medical Center — Poznan, Wielkopolska, Poland
Aidport Sp. z o.o. — Skorzewo, Wielkopolska, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz — Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center — Gdansk, Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
Narodowy Instytut Onkologii — Warsaw, Poland
Szpital Szpecjalistyczny w Walbrzychu — Wałbrzych, Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii — Lodz, Łódź Voivodeship, Poland
National University Hospital Singapore — Singapore, Singapore
National Cancer Centre of Singapore — Singapore, Singapore
Tan Tock Seng Hospital — Singapore, Singapore
St. Vincent Hospital - The Catholic University of Korea — Suwon, Gyeonggi-do, South Korea
Gachon University Gil Medical Center — Incheon, Namdong-Gu, South Korea
Inje University Busan Paik Hospital — Busan, South Korea
Dong-A University Hospital — Busan, South Korea
Pusan National University Hospital — Busan, South Korea
Yeyungnam University Medical Center — Daegu, South Korea
Keimyung University Dongsan Hospital — Daegu, South Korea
Asan Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Yeouido St. Marys Hospital — Seoul, South Korea
Seoul St Marys Hospital — Seoul, South Korea
Hospital Clinico Universitario Santiago de Compostela — Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen del Rocio — Seville, Andalusia, Spain
Son Espases University Hospital — Palma, Balearic Islands, Spain
Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
Hospital Universitari Parc Tauli — Sabadell, Barcelona, Spain
Hospital Universitari Mutua Terrassa — Terrassa, Barcelona, Spain
Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain
Complejo Hospitalario Universitario de a Coruna — A Coruña, Galicia, Spain
Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Navarra — Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain
Hospital Sant Pau — Barcelona, Spain
Institut Catala d'Oncologia — Barcelona, Spain
Hospital Virgen De Las Nieves De Granada — Granada, Spain
Hospital Universitario Infanta Leonor — Madrid, Spain
Hospital Universitario Ramon y Cajal — Madrid, Spain
Fundacion Jimenez Diaz University Hospital — Madrid, Spain
Hospital Universitario HM Sanchinarro — Madrid, Spain
Hospital Universitario Virgen Macarena — Seville, Spain
Hospital General Universitario de Toledo — Toledo, Spain
Instituto Valenciano de Oncologia — Valencia, Spain
University Hospital Doctor Peset — Valencia, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) — Valencia, Spain
Chang Gung Medical Foundation Chia Yi Branch — Buzi, Chiayi County, Taiwan
Chang Gung Memorial Hospital - Linkou Branch — Taoyuan, Hunan Province, Taiwan
Chang Gung Medical Foundation Kaohsiung Branch — Niaosong, Kaohsiung, Taiwan
Changhua Christian Hospital — Changhua, Taiwan
Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho Hospital — New Taipei City, Taiwan
Wanfang Hospital — Taipei, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Tri-Service General Hospital — Taipei, Taiwan
Chulalongkorn University — Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand
Sriraj Hospital — Bangkok, Thailand
Chaing Mai University — Chiang Mai, Thailand
Faculty of Medicine — Khon Kaen, Thailand
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital — Yenimahalle, Ankara, Turkey (Türkiye)
VM Medical Park Mersin Hospital — Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital — Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Gazi University Faculty of Medicine — Ankara, Yenimahalle, Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine — Istanbul, Turkey (Türkiye)
Ege University — Izmir, Turkey (Türkiye)
Dokuz Eylul University — Izmir, Turkey (Türkiye)
Sakarya University Medical Faculty — Sakarya, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi — Samsun, Turkey (Türkiye)
NHS Grampian: Aberdeen Royal Infirmary — Aberdeen, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust — Uxbridge, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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