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
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)
- Diffuse Large B-cell Lymphoma (DLBCL)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Regeneron Pharmaceuticals
- Enrolment target
- 904
- Started
- 13 December 2023
- Main results due
- 30 March 2028
- Study sites
- 190
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(190)
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Recruiting
University of California Irvine Medical Center
Orange, California, United States
Recruiting
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Recruiting
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana, United States
Recruiting
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States
Recruiting
University of Kentucky
Lexington, Kentucky, United States
Recruiting
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
Henry Ford Health System
Detroit, Michigan, United States
Recruiting
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Stony Brook University Hospital
Stony Brook, New York, United States
Recruiting
Clinical Research Alliance Inc
Westbury, New York, United States
Withdrawn
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
East Carolina University
Greenville, North Carolina, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Center for Oncology and Blood Disorders
Houston, Texas, United States
Withdrawn
Community Cancer Trials of Utah
Ogden, Utah, United States
Recruiting
Prohealth Care Inc
Waukesha, Wisconsin, United States
Withdrawn
Liverpool Hospital
Liverpool, New South Wales, Australia
Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Recruiting
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia
Recruiting
Pindara Private Hospital
Benowa, Queensland, Australia
Recruiting
Epworth Freemasons
East Melbourne, Victoria, Australia
Recruiting
Landeskrankenhaus Hochsteiermark
Leoben, Styria, Austria
Recruiting
Kepler University Hospital
Linz, Upper Austria, Austria
Recruiting
Medical University Graz
Graz, Austria
Recruiting
Medical University of Vienna
Vienna, Austria
Recruiting
Hanusch Krankenhaus
Vienna, Austria
Recruiting
Klinikum Wels-Grieskirchen
Wels, Austria
Recruiting
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium
Recruiting
Centre Hospitalier Regional de Verviers
Verviers, Liege, Belgium
Recruiting
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Recruiting
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium
Recruiting
Institut Jules Bordet
Brussels, Belgium
Recruiting
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil
Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Recruiting
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, Brazil
Recruiting
Fundacao Pio XII - Hospital de Amor
Barretos, São Paulo, Brazil
Recruiting
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Recruiting
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil
Recruiting
Instituto Americas
Rio de Janeiro, Brazil
Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Recruiting
AC Camargo Cancer Center
São Paulo, Brazil
Recruiting
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, Brazil
Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Recruiting
Casa de Saude Santa Marcelina
São Paulo, Brazil
Recruiting
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile
Recruiting
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile
Recruiting
Inmunocel
Santiago, Santiago Metropolitan, Chile
Recruiting
Clinica Alemana de Santiago
Santiago, Chile
Recruiting
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia
Recruiting
University Hospital Brno
Brno, South Moravian, Czechia
Recruiting
Showing 60 of 190 sites — filter to narrow it down. 178 of the 190 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06091865. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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