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 (OLYMPIA-3)

May 14, 2026 updated by: Regeneron Pharmaceuticals

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

904

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre - Wesley
      • Benowa, Queensland, Australia, 4217
        • Recruiting
        • Pindara Private Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3121
        • Recruiting
        • Epworth Freemasons
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University Graz
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
      • Vienna, Austria, 1140
        • Recruiting
        • Hanusch Krankenhaus
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen
    • Styria
      • Leoben, Styria, Austria, 8700
        • Recruiting
        • Landeskrankenhaus Hochsteiermark
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Kepler University Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Recruiting
        • Institut Jules Bordet
    • Antwerp
      • Herentals, Antwerp, Belgium, 2200
        • Recruiting
        • AZ St.-Elisabeth Herentals vzw
    • Liege
      • Verviers, Liege, Belgium, 4800
        • Recruiting
        • Centre Hospitalier Regional de Verviers
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ DELTA
  • Chile
      • Santiago, Chile, 7650568
        • Recruiting
        • Clínica Alemana de Santiago
    • Las Condes
      • Santiago, Las Condes, Chile, 7620157
        • Recruiting
        • Hospital Clinico Universidad de Los Andes
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7560907
        • Recruiting
        • Centro Oncologia de Precision Universidad Mayor
      • Santiago, Santiago Metropolitan, Chile, 7580206
        • Recruiting
        • Inmunocel
  • Czechia
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 10034
        • Recruiting
        • University Hospital Kralovske Vinohrady
    • East Bohemia
      • Hradec Králové, East Bohemia, Czechia, 50005
        • Recruiting
        • University hospital Hradec Králové
  • France
      • Angers, France, 49000
        • Recruiting
        • Centre Hospitalier Universitaire Angers
      • Metz-Tessy, France, 74374
        • Recruiting
        • Change Annecy
      • Nîmes, France, 30029
        • Recruiting
        • CHU Nimes Institut de Cancerologie
      • Paris, France, 75571
        • Recruiting
        • Assistance Publique-Hopitaux de Paris (AP-HP)
      • Saint-Etienne, France, 42055
        • Recruiting
        • CHU de Saint-Etienne
    • Brittany Region
      • Rennes, Brittany Region, France, 35033
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) Rennes
    • Centre-Val de Loire
      • Tours, Centre-Val de Loire, France, 37044
        • Recruiting
        • CHRU de Tours
    • Gironde
      • Bordeaux, Gironde, France, 33077
        • Recruiting
        • Polyclinique Bordeaux Nord Aquitaine
    • New Aquitaine
      • Pessac, New Aquitaine, France, 33600
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Bordeaux
      • Poitiers, New Aquitaine, France, 86000
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
    • Nord
      • Lille, Nord, France, 5900
        • Recruiting
        • Hôpital Saint Vincent-de-Paul
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Recruiting
        • Nantes University Hospital
    • Savoie
      • Chambéry, Savoie, France, 73000
        • Recruiting
        • Centre Hospitalier Metropole Savoie
    • Île-de-France Region
      • Argenteuil, Île-de-France Region, France, 95100
        • Recruiting
        • Hopital Victor Dupouy Argenteuil
      • Bobigny, Île-de-France Region, France, 93000
        • Recruiting
        • Avicenne Hospital
      • Villejuif, Île-de-France Region, France, 94800
        • Recruiting
        • Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • University Hospital Carl Gustav Carus
      • Kiel, Germany, 24116
        • Recruiting
        • Stadtisches Krankenhaus Kiel
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Recruiting
        • Robert-Bosch-Krankenhaus
    • Gmund
      • Mutlangen, Gmund, Germany, D-73557
        • Recruiting
        • Kliniken Ostalb Stauferklinikum Schwab Gmund
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 15236
        • Recruiting
        • Clinic Frankfurt (Oder)
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Recruiting
        • University Hospital Essen
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Hematological Praxis Dresden
  • Ireland
      • Dublin, Ireland, D08
        • Recruiting
        • St James Hospital and Trinity College Dublin
    • Leinster
      • Dublin, Leinster, Ireland, D09V2N0
        • Withdrawn
        • Beaumont Hospital
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Samson Assuta Ashdod University Hospital
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 91200
        • Recruiting
        • Hadassah Medical Center
      • Nahariya, Israel, 2210001
        • Recruiting
        • Galilee Medical Center
      • Tel Aviv, Israel, 64239
        • Recruiting
        • The Tel Aviv Sourasky Medical Center
    • Tel Aviv
      • Tel Litwinsky, Tel Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center
  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
      • Modena, Italy, 41124
        • Recruiting
        • A.O.U. di Modena
      • Naples, Italy, 80131
        • Recruiting
        • Federico II University
      • Novara, Italy, 28100
        • Recruiting
        • AOU Maggiore della Carità
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San matteo
      • Perugia, Italy, 06132
        • Recruiting
        • Azienda Ospedaliera di Perugia
      • Ravenna, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci
      • Turin, Italy, 10126
        • Recruiting
        • Hematology - Città della Salute e della Scienza di Torino
      • Udine, Italy, 33100
        • Recruiting
        • Santa Maria della Misericordia
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900
        • Recruiting
        • ASST Monza Ospedale San Gerardo
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • Recruiting
        • Hospital Tg Ampuan Afzan
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88200
        • Recruiting
        • Hospital Queen Elizabeth
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Recruiting
        • Hospital Ampang
      • Subang Jaya, Selangor, Malaysia, 47500
        • Recruiting
        • Subang Jaya Medical Center
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Withdrawn
        • Szpital Uniwersytecki Nr2 Bydgoszcz
      • Gdansk, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
      • Lublin, Poland, 20-954
        • Recruiting
        • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Wałbrzych, Poland, 58-300
        • Recruiting
        • Szpital Szpecjalistyczny w Walbrzychu
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-510
        • Recruiting
        • Matopolskie Centrum Medyczne S.C.
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60185
        • Withdrawn
        • Pratia Poznan Medical Center
      • Skorzewo, Wielkopolska, Poland, 60185
        • Recruiting
        • Aidport
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-510
        • Recruiting
        • Wielospecjalistyczne Centrum Onkologii i Traumatologii
  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital Singapore
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre of Singapore
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
      • Busan, South Korea, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
      • Daegu, South Korea, 42415
        • Recruiting
        • Yeyungnam University Medical Center
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 07345
        • Recruiting
        • Yeouido St. Marys Hospital
      • Seoul, South Korea, 137-701
        • Recruiting
        • Seoul St Marys Hospital
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16247
        • Recruiting
        • St. Vincent Hospital - The Catholic University of Korea
    • Namdong-Gu
      • Incheon, Namdong-Gu, South Korea, 21565
        • Recruiting
        • Gachon University Gil Medical Center
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Sant Pau
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Virgen De Las Nieves De Granada
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28040
        • Recruiting
        • Fundacion Jimenez Diaz University Hospital
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Toledo, Spain, 45007
        • Withdrawn
        • Hospital General Universitario de Toledo
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncología
      • Valencia, Spain, 46026
        • Recruiting
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
      • Valencia, Spain, 46017
        • Recruiting
        • University Hospital Doctor Peset
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario Santiago de Compostela
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07120
        • Recruiting
        • Son Espases University Hospital
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua Terrassa
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario De Navarra
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 00116
        • Recruiting
        • Wanfang Hospital
    • Chiayi County
      • Buzi, Chiayi County, Taiwan, 613
        • Recruiting
        • Chang Gung Medical Foundation Chia Yi Branch
    • Hunan Province
      • Taoyuan, Hunan Province, Taiwan, 33305
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou Branch
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Sriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Chaing Mai University
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine
    • Krung Thep Maha Nakhon [Bangko]
      • Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
        • Recruiting
        • Chulalongkorn University
  • Turkey (Türkiye)
      • Beşevler, Turkey (Türkiye), 6500
        • Recruiting
        • Gazi Universitesi
      • Istanbul, Turkey (Türkiye), 34418
        • Recruiting
        • Istanbul University Istanbul Faculty of Medicine
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege University
      • Izmir, Turkey (Türkiye), 35340
        • Recruiting
        • Dokuz Eylul University
      • Sakarya, Turkey (Türkiye), 54290
        • Recruiting
        • Sakarya University Medical Faculty
      • Samsun, Turkey (Türkiye), 55239
        • Recruiting
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
    • Mersin
      • Mezitli, Mersin, Turkey (Türkiye), 33200
        • Recruiting
        • VM Medical Park Mersin Hospital
    • Suleymanpasa
      • Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59100
        • Recruiting
        • Tekirdag Namik Kemal University Hospital
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • NHS Grampian: Aberdeen Royal Infirmary
      • Uxbridge, United Kingdom, UB8 3NN
        • Recruiting
        • The Hillingdon Hospitals NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California (UC) Davis
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St Vincent Ascension at Peyton Manning Childrens Hospital
      • Noblesville, Indiana, United States, 46062
        • Recruiting
        • Investigative Clinical Research of Indiana
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Matthew Matasar
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Hospital
      • Westbury, New York, United States, 11590
        • Withdrawn
        • Clinical Research Alliance Inc
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Center for Oncology and Blood Disorders
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Community Cancer Trials of Utah
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Withdrawn
        • Prohealth Care Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Odronextamab + CHOP
Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).
Drug: Odronextamab
Odronextamab will be administered by intravenous (IV) infusion
Other Names:
  • REGN1979
  • Ordspono™
Drug: Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Other Names:
  • Cytoxan®
Drug: Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Other Names:
  • Adriamycin®
Drug: Vincristine
Vincristine will be administered IV as part of chemotherapy
Other Names:
  • Oncovin®
  • Vincasar PFS®
Drug: Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Other Names:
  • Deltasone®/OMNIPRED®
Active Comparator: Rituximab + CHOP
Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.
Drug: Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Other Names:
  • Cytoxan®
Drug: Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Other Names:
  • Adriamycin®
Drug: Vincristine
Vincristine will be administered IV as part of chemotherapy
Other Names:
  • Oncovin®
  • Vincasar PFS®
Drug: Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Other Names:
  • Deltasone®/OMNIPRED®
Drug: Rituximab
Rituximab will be administered IV, or subcutaneously (SC)
Other Names:
  • RITUXAN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of TEAEs
Time Frame: Up to 2 years
Part 1
Up to 2 years
Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: Up to 35 days
Part 1A
Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years
Part 1
Up to 2 years
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Time Frame: Up to 5 years
Part 2
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR as assessed by local investigators
Time Frame: Up to 22 weeks
Part 1 and Part 2
Up to 22 weeks
Odronextamab concentrations in serum when administered with CHOP
Time Frame: Up to 22 weeks
Part 1 and Part 2
Up to 22 weeks
PFS assessed by local investigator review
Time Frame: Up to 5 years
Part 2
Up to 5 years
EFS assessed by local investigator review
Time Frame: Up to 5 years
Part 2
Up to 5 years
BOR assessed by ICR
Time Frame: Up to 22 weeks
Part 2
Up to 22 weeks
DOR assessed by ICR
Time Frame: Up to 5 years
Part 2
Up to 5 years
Incidence of TEAEs
Time Frame: Up to 2 years
Part 2
Up to 2 years
Severity of TEAEs
Time Frame: Up to 2 years
Part 2
Up to 2 years
Change in score of the Functional Assessment of Cancer Therapy-General (FACT-G ) GP5 item
Time Frame: Up to 5 years
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).
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
Part 2
Up to 5 years
Change in physical functioning as measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C) 30
Time Frame: Up to 5 years
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.
Up to 5 years
Change in patient reported outcomes, as measured by EORTC QLQ-C30
Time Frame: Up to 5 years
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.
Up to 5 years
Change in patient reported outcomes, as measured by Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS)
Time Frame: Up to 5 years
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.
Up to 5 years
Change in patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS)
Time Frame: Up to 5 years
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).
Up to 5 years
Change in patient reported outcomes, as measured by Patient Global Impression of Change (PGIC)
Time Frame: Up to 5 years
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.
Up to 5 years
Change in patient reported outcomes, as measured by EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
Time Frame: Up to 5 years
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".
Up to 5 years
Event-Free Survival (EFS) assessed by ICR
Time Frame: Up to 5 years
Part 2
Up to 5 years
Complete Response (CR) assessed by ICR
Time Frame: Up to 22 weeks
Part 2
Up to 22 weeks
Best Overall Response (BOR) as assessed by local investigators
Time Frame: Up to 22 weeks
Part 1 and Part 2
Up to 22 weeks
Duration of Response (DOR) as assessed by local investigators
Time Frame: Up to 5 years
Part 1 and Part 2
Up to 5 years
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
Time Frame: Up to 22 weeks
Part 1 and Part 2
Up to 22 weeks
Magnitude of ADA to odronextamab
Time Frame: Up to 22 weeks
Part 1 and Part 2
Up to 22 weeks
Minimal Residual Disease (MRD) status
Time Frame: Up to 22 weeks
Part 2
Up to 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

September 12, 2029

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1979-ONC-2105
  • 2022-502785-25-00 (Ctis: EUCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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