AzTrials
AzTrials

Diffuse Large B-cell Lymphoma (DLBCL)Phase 3OLYMPIA-3NCT06091865

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 study testing Odronextamab, Rituximab and Cyclophosphamide in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Regeneron Pharmaceuticals at 195 sites in 21 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma (DLBCL)
What is being tested?
Odronextamab, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
904 participants
Where
195 sitesin 21 countries
Study dates
13 Dec 2023to 12 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Life expectancy ≥ 12 months
  • International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
  • Adequate hematologic and organ function, as defined in the protocol.

Who cannot join

  • Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
  • Another active malignancy, significant active disease or medical condition, as described in the protocol
  • Peripheral neuropathy Grade ≥3
  • 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.
  • 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
  • Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
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  • Allergy/hypersensitivity to study drugs, as described in the protocol
  • 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

Trial locations and contacts

195 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

195 sites in 21 countries

United States23 sites, 19 recruiting

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Recruiting

  • Center for Oncology and Blood Disorders

    Houston, Texas, 77030

    Withdrawn

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

  • St Vincent Ascension at Peyton Manning Childrens Hospital

    Indianapolis, Indiana, 46260

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Investigative Clinical Research of Indiana

    Noblesville, Indiana, 46062

    Recruiting

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55901

    Recruiting

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Withdrawn

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Recruiting

  • Prohealth Care Inc

    Waukesha, Wisconsin, 53188

    Withdrawn

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

    Withdrawn

Other trials in United States

Spain23 sites, 22 recruiting

  • Complejo Hospitalario Universitario de a Coruna

    A Coruña, Galicia, 15006

    Recruiting

  • Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Recruiting

  • Hospital Sant Pau

    Barcelona, 08041

    Recruiting

  • Institut Catala d'Oncologia

    Barcelona, 08908

    Recruiting

  • Hospital Virgen De Las Nieves De Granada

    Granada, 18014

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Recruiting

  • Son Espases University Hospital

    Palma, Balearic Islands, 07120

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital Universitari Parc Tauli

    Sabadell, Barcelona, 08208

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona, 08221

    Recruiting

  • Hospital General Universitario de Toledo

    Toledo, 45007

    Withdrawn

  • Instituto Valenciano de Oncologia

    Valencia, 46009

    Recruiting

  • University Hospital Doctor Peset

    Valencia, 46017

    Recruiting

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

    Recruiting

Other trials in Spain

Brazil20 sites, 20 recruiting

  • Fundacao Pio XII - Hospital de Amor

    Barretos, São Paulo, 14784-400

    Recruiting

  • Instituto Mario Penna de Ensino Pesquisa e Inovacao

    Belo Horizonte, Minas Gerais, 30380-472

    Recruiting

  • Instituto Tacchini de Pesquisa em Saude

    Bento Gonçalves, Rio Grande do Sul, 95700-084

    Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

    Recruiting

  • Uopeccan Hospital do Cancer de Cascavel

    Cascavel, Paraná, 85806-300

    Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

    Recruiting

  • Amaral Carvalho Hospital

    Jaú, São Paulo, 17210-080

    Recruiting

  • Centro de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201-260

    Recruiting

  • Animi Unidade de Tratamento Oncologico Ltda

    Lages, Santa Catarina, 88501-001

    Recruiting

  • Liga Norte Riograndense Contra o Cancer

    Natal, Rio Grande do Norte, 59062-000

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Centro Gaucho Integrado

    Porto Alegre, Rio Grande do Sul, 90110-270

    Recruiting

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva

    Rio de Janeiro, 20231050

    Recruiting

  • Instituto Americas

    Rio de Janeiro, 22793-334

    Recruiting

  • Ensino e Terapia de Inovacao Clinica Amo (Etica)

    Salvador, Estado de Bahia, 41950-640

    Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903

    Recruiting

  • AC Camargo Cancer Center

    São Paulo, 01509-010

    Recruiting

  • Clinical Hospital of Medicine School at Sao Paulo University

    São Paulo, 05403-000

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, 05403-010

    Recruiting

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070

    Recruiting

Other trials in Brazil

France19 sites, 17 recruiting

  • Centre Hospitalier Universitaire Angers

    Angers, 49000

    Withdrawn

  • Hopital Victor Dupouy Argenteuil

    Argenteuil, Île-de-France Region, 95100

    Recruiting

  • Avicenne Hospital

    Bobigny, Île-de-France Region, 93000

    Withdrawn

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, Gironde, 33077

    Recruiting

  • Centre Hospitalier Metropole Savoie

    Chambéry, Savoie, 73000

    Recruiting

  • Hopital Saint Vincent-de-Paul

    Lille, Nord, 5900

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception

    Marseille, 130005

    Recruiting

  • Change Annecy

    Metz-Tessy, 74374

    Recruiting

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093

    Recruiting

  • CHU Nimes Institut de Cancerologie

    Nîmes, 30029

    Recruiting

  • Assistance Publique-Hopitaux de Paris (AP-HP)

    Paris, 75571

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux

    Pessac, New Aquitaine, 33600

    Recruiting

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, New Aquitaine, 86000

    Recruiting

  • Centre Hospitalier de Cornouaille Quimper Concarneau

    Quimper, Brittany Region, 29107

    Recruiting

  • Centre Hospitalier Universitaire (CHU) Rennes

    Rennes, Brittany Region, 35033

    Recruiting

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

    Recruiting

  • CHRU de Tours

    Tours, Centre-Val de Loire, 37044

    Recruiting

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800

    Recruiting

Other trials in France

Italy15 sites, 15 recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forli-Cesena, 47014

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda - Main Address

    Milan, 20162

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • A.O.U. di Modena

    Modena, 41124

    Recruiting

  • ASST Monza Ospedale San Gerardo

    Monza, Monza E Brianza, 20900

    Recruiting

  • Federico II University

    Naples, 80131

    Recruiting

  • AOU Maggiore della Carita

    Novara, 28100

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia, 06132

    Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, 00128

    Recruiting

  • Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin

    Turin, Piedmont, 10137

    Recruiting

  • Hematology - Città della Salute e della Scienza di Torino

    Turin, 10126

    Recruiting

  • Santa Maria della Misericordia

    Udine, 33100

    Recruiting

  • Ospedale di Circolo e Fondazione Macchi Varese

    Varese, 21100

    Recruiting

Other trials in Italy

South Korea11 sites, 11 recruiting

  • Inje University Busan Paik Hospital

    Busan, 47392

    Recruiting

  • Dong-A University Hospital

    Busan, 49201

    Recruiting

  • Pusan National University Hospital

    Busan, 49241

    Recruiting

  • Yeyungnam University Medical Center

    Daegu, 42415

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Yeouido St. Marys Hospital

    Seoul, 07345

    Recruiting

  • Seoul St Marys Hospital

    Seoul, 137-701

    Recruiting

  • St. Vincent Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247

    Recruiting

Other trials in South Korea

Germany10 sites, 8 recruiting

  • Vivantes Klinikum Am Urban

    Berlin, 10967

    Recruiting

  • Hematological Praxis Dresden

    Dresden, Saxony, 01307

    Recruiting

  • University Hospital Carl Gustav Carus

    Dresden, 01307

    Withdrawn

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45122

    Recruiting

  • Clinic Frankfurt (Oder)

    Frankfurt am Main, Hesse, 15236

    Recruiting

  • UKS Homburg

    Homburg, Saarland, 66421

    Recruiting

  • Stadtisches Krankenhaus Kiel

    Kiel, 24116

    Withdrawn

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, Rhineland-Palatinate, 55131

    Recruiting

  • Kliniken Ostalb Stauferklinikum Schwab Gmund

    Mutlangen, Gmund, D-73557

    Recruiting

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

    Recruiting

Other trials in Germany

Poland10 sites, 8 recruiting

  • Szpital Uniwersytecki Nr2 Bydgoszcz

    Bydgoszcz, 85-168

    Withdrawn

  • Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center

    Gdansk, 80-952

    Recruiting

  • Matopolskie Centrum Medyczne S.C.

    Krakow, Lesser Poland Voivodeship, 30-510

    Recruiting

  • Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, Łódź Voivodeship, 93-510

    Recruiting

  • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

    Recruiting

  • Pratia Poznan Medical Center

    Poznan, Wielkopolska, 60185

    Withdrawn

  • Aidport Sp. z o.o.

    Skorzewo, Wielkopolska, 60185

    Recruiting

  • Szpital Szpecjalistyczny w Walbrzychu

    Wałbrzych, 58-300

    Recruiting

  • Narodowy Instytut Onkologii

    Warsaw, 02-781

    Recruiting

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, Lower Silesian Voivodeship, 50-367

    Recruiting

Other trials in Poland

Taiwan9 sites, 9 recruiting

  • Chang Gung Medical Foundation Chia Yi Branch

    Buzi, Chiayi County, 613

    Recruiting

  • Changhua Christian Hospital

    Changhua, 50006

    Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

    Recruiting

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561

    Recruiting

  • Chang Gung Medical Foundation Kaohsiung Branch

    Niaosong, Kaohsiung, 83301

    Recruiting

  • Wanfang Hospital

    Taipei, 00116

    Recruiting

  • National Taiwan University Hospital

    Taipei, 106

    Recruiting

  • Tri-Service General Hospital

    Taipei, 11490

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, Hunan Province, 33305

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)9 sites, 9 recruiting

  • Gazi University Faculty of Medicine

    Ankara, Yenimahalle, 6500

    Recruiting

  • Istanbul University Istanbul Faculty of Medicine

    Istanbul, 34418

    Recruiting

  • Ege University

    Izmir, 35100

    Recruiting

  • Dokuz Eylul University

    Izmir, 35340

    Recruiting

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin, 33200

    Recruiting

  • Sakarya University Medical Faculty

    Sakarya, 54290

    Recruiting

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55239

    Recruiting

  • Tekirdag Namik Kemal University Hospital

    Tekirdağ, Suleymanpasa, 59100

    Recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Yenimahalle, Ankara, 06200

    Recruiting

Other trials in Turkey (Türkiye)

Austria6 sites, 6 recruiting

  • Medical University Graz

    Graz, 8036

    Recruiting

  • Landeskrankenhaus Hochsteiermark

    Leoben, Styria, 8700

    Recruiting

  • Kepler University Hospital

    Linz, Upper Austria, 4020

    Recruiting

  • Medical University of Vienna

    Vienna, 1090

    Recruiting

  • Hanusch Krankenhaus

    Vienna, 1140

    Recruiting

  • Klinikum Wels-Grieskirchen

    Wels, 4600

    Recruiting

Other trials in Austria

Israel6 sites, 6 recruiting

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

    Recruiting

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 91200

    Recruiting

  • Galilee Medical Center

    Nahariya, 2210001

    Recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

  • The Chaim Sheba Medical Center

    Tel HaShomer, Tel Aviv, 5265601

    Recruiting

Other trials in Israel

Australia5 sites, 5 recruiting

  • Icon Cancer Centre - Wesley

    Auchenflower, Queensland, 4066

    Recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Recruiting

  • Epworth Freemasons

    East Melbourne, Victoria, 3121

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • Institut Jules Bordet

    Brussels, 1000

    Recruiting

  • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • AZ St.-Elisabeth Herentals vzw

    Herentals, Antwerp, 2200

    Recruiting

  • Algemeen Ziekenhuis AZ Delta

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Centre Hospitalier Regional de Verviers

    Verviers, Liege, 4800

    Recruiting

Other trials in Belgium

Malaysia5 sites, 5 recruiting

  • Hospital Ampang

    Ampang, Selangor, 68000

    Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88200

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

    Recruiting

  • Hospital Tg Ampuan Afzan

    Kuantan, Pahang, 25200

    Recruiting

  • Subang Jaya Medical Center

    Subang Jaya, Selangor, 47500

    Recruiting

Other trials in Malaysia

Chile4 sites, 4 recruiting

  • Hospital Clinico Universidad de Los Andes

    Santiago, Las Condes, 7620157

    Recruiting

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Santiago Metropolitan, 7560907

    Recruiting

  • Inmunocel

    Santiago, Santiago Metropolitan, 7580206

    Recruiting

  • Clinica Alemana de Santiago

    Santiago, 7650568

    Recruiting

Other trials in Chile

Czechia4 sites, 4 recruiting

  • University Hospital Brno

    Brno, South Moravian, 62500

    Recruiting

  • University Hospital Hradec Kralove

    Hradec Králové, East Bohemia, 50005

    Recruiting

  • University Hospital Kralovske Vinohrady

    Prague, 10034

    Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 12808

    Recruiting

Other trials in Czechia

Thailand4 sites, 4 recruiting

  • Chulalongkorn University

    Bangkok, Krung Thep Maha Nakhon [Bangko], 10330

    Recruiting

  • Sriraj Hospital

    Bangkok, 10700

    Recruiting

  • Chaing Mai University

    Chiang Mai, 50200

    Recruiting

  • Faculty of Medicine

    Khon Kaen, 40002

    Recruiting

Other trials in Thailand

Singapore3 sites, 3 recruiting

  • National University Hospital Singapore

    Singapore, 119074

    Recruiting

  • National Cancer Centre of Singapore

    Singapore, 168583

    Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433

    Recruiting

Other trials in Singapore

Ireland2 sites

  • Beaumont Hospital

    Dublin, Leinster, D09V2N0

    Withdrawn

  • St James Hospital and Trinity College Dublin

    Dublin, D08

    Withdrawn

Other trials in Ireland

United Kingdom2 sites, 2 recruiting

  • NHS Grampian: Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Recruiting

  • The Hillingdon Hospitals NHS Foundation Trust

    Uxbridge, UB8 3NN

    Recruiting

Other trials in United Kingdom

About this study

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)

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.

Read more

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
Being tested
Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Keywords
Non-Hodgkin Lymphomas (NHL), B-cell Non-Hodgkin Lymphomas (B-NHL), Diffuse Large B-cell Lymphoma, Odronextamab, Anti-CD20 × anti-CD3 bispecific antibody
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdronextamabDrug

    Also called REGN1979, Ordspono™

    Odronextamab will be administered by intravenous (IV) infusion

  • RituximabDrug

    Also called RITUXAN®

    Rituximab will be administered IV, or subcutaneously (SC)

  • CyclophosphamideDrug

    Also called Cytoxan®

    Cyclophosphamide will be administered IV as part of chemotherapy

  • DoxorubicinDrug

    Also called Adriamycin®

    Doxorubicin will be administered IV as part of chemotherapy

  • VincristineDrug

    Also called Oncovin®, Vincasar PFS®

    Vincristine will be administered IV as part of chemotherapy

  • Prednisone/PrednisoloneDrug

    Also called Deltasone®/OMNIPRED®

    Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Study groups in NCT06091865
Study groupRoleWhat they receive
Odronextamab + CHOPExperimentalPart 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).
Receives: Drug: Odronextamab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone
Rituximab + CHOPActive comparatorPart 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs)

    Part 1A

    Measured: Up to 35 days

  2. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Part 1

    Measured: Up to 2 years

  3. Severity of TEAEs

    Part 1

    Measured: Up to 2 years

  4. Progression Free Survival (PFS), assessed by Independent Central Review (ICR)

    Part 2

    Measured: Up to 5 years

Secondary outcomes (23)

  1. Event-Free Survival (EFS) assessed by ICR

    Part 2

    Measured: Up to 5 years

  2. Complete Response (CR) assessed by ICR

    Part 2

    Measured: Up to 22 weeks

  3. Overall Survival (OS)

    Part 2

    Measured: Up to 5 years

  4. Best Overall Response (BOR) as assessed by local investigators

    Part 1 and Part 2

    Measured: Up to 22 weeks

  5. CR as assessed by local investigators

    Part 1 and Part 2

    Measured: Up to 22 weeks

  6. Duration of Response (DOR) as assessed by local investigators

    Part 1 and Part 2

    Measured: Up to 5 years

  7. Odronextamab concentrations in serum when administered with CHOP

    Part 1 and Part 2

    Measured: Up to 22 weeks

  8. Occurrence of Anti-Drug Antibodies (ADA) to odronextamab

    Part 1 and Part 2

    Measured: Up to 22 weeks

  9. Magnitude of ADA to odronextamab

    Part 1 and Part 2

    Measured: Up to 22 weeks

  10. PFS assessed by local investigator review

    Part 2

    Measured: Up to 5 years

  11. EFS assessed by local investigator review

    Part 2

    Measured: Up to 5 years

  12. BOR assessed by ICR

    Part 2

    Measured: Up to 22 weeks

  13. DOR assessed by ICR

    Part 2

    Measured: Up to 5 years

  14. Incidence of TEAEs

    Part 2

    Measured: Up to 2 years

  15. Severity of TEAEs

    Part 2

    Measured: Up to 2 years

  16. Minimal Residual Disease (MRD) status

    Part 2

    Measured: Up to 22 weeks

  17. Change in physical functioning as measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C) 30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  18. Change in patient reported outcomes, as measured by EORTC QLQ-C30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  19. Change in patient reported outcomes, as measured by Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS)

    Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

    Measured: Up to 5 years

  20. Change in patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS)

    Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).

    Measured: Up to 5 years

  21. Change in patient reported outcomes, as measured by Patient Global Impression of Change (PGIC)

    Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.

    Measured: Up to 5 years

  22. Change in patient reported outcomes, as measured by EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)

    Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

    Measured: Up to 5 years

  23. Change in score of the Functional Assessment of Cancer Therapy-General (FACT-G ) GP5 item

    Part 2 A single item (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start13 Dec 2023
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion12 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
904 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091865
Sponsor's protocol ID
R1979-ONC-2105
Other IDs
2022-502785-25-00
Acronym
OLYMPIA-3
Status last verified
Nov 2026
First submitted
13 Oct 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Odronextamab, Rituximab and Cyclophosphamide in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Regeneron Pharmaceuticals at 195 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Spain, Brazil, France, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) (time frame: Up to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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