A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma (OLYMPIA-1)

May 18, 2026 updated by: Regeneron Pharmaceuticals

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).

The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.

The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). 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
  • 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)
  • How the study drug affects quality of life and ability to complete routine daily activities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

822

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
        • Ingham Institute
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre - Wesley
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
      • East Melbourne, Victoria, Australia, 3121
        • Recruiting
        • Epworth Freemasons
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital - Melbourne
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Hospital and Monash University
  • Austria
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Gmbh, Elisabethinen
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
      • Vienna, Austria, 1140
        • Recruiting
        • Hanusch Krankenhaus
    • Osterreich
      • Linz, Osterreich, Austria, 4010
        • Recruiting
        • Ordensklinikum Linz
  • Belgium
      • Antwerp, Belgium, 2060
        • Withdrawn
        • Ziekenhuis Netwerk Antwerpen Stuivenberg
      • Brussels, Belgium, 1000
        • Withdrawn
        • Institut Jules Bordet
    • Antwerp
      • Herentals, Antwerp, Belgium, 2200
        • Recruiting
        • AZ St.-Elisabeth Herentals vzw
    • Hainaut
      • La Louvière, Hainaut, Belgium, 7100
        • Withdrawn
        • Hopital de Jolimont
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Withdrawn
        • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
  • Brazil
      • Brasília, Brazil, 70390-140
        • Recruiting
        • Instituto DOr de Pesquisa e Ensino Df Star
      • Rio de Janeiro, Brazil, 22793-334
        • Recruiting
        • Instituto Americas
      • Rio de Janeiro, Brazil, 20231050
        • Recruiting
        • Instituto Nacional de Cancer Jose Alencar Gomes da Silva
      • São Paulo, Brazil, 01323-903
        • Recruiting
        • Hospital Alemao Oswaldo Cruz
      • São Paulo, Brazil, 01509010
        • Recruiting
        • AC Camargo Cancer Center
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Clinical Hospital of Medicine School at Sao Paulo University
      • São Paulo, Brazil, 08270-070
        • Recruiting
        • Casa de Saude Santa Marcelina
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41950640
        • Recruiting
        • Ensino e Terapia de Inovacao Clinica Amo (Etica)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-420
        • Recruiting
        • Instituto Mario Pena de Ensino Pesquisa e Inovacao
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
        • Recruiting
        • Instituto do Cancer em Hospital Sao Vicente de Paulo
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89201260
        • Recruiting
        • Centro de Hematologia e Oncologia
      • Lages, Santa Catarina, Brazil, 88501-001
        • Recruiting
        • Animi Unidade de Tratamento Oncologico Ltda
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundacao Pio XII Hospital de Amor
      • Jaú, São Paulo, Brazil, 17210080
        • Recruiting
        • Amaral Carvalho Hospital
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4J8
        • Recruiting
        • Tom Baker Cancer Center
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • Saint John Regional Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
      • Québec, Quebec, Canada, G1J1Z4
        • Recruiting
        • CHU de Québec - Université Laval
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Recruiting
        • Fundacion Arturo Lopez Perez
      • Santiago, Santiago Metropolitan, Chile, 7580206
        • Recruiting
        • Inmunocel
      • Santiago, Santiago Metropolitan, Chile, 7650620
        • Recruiting
        • Clínica Alemana de Santiago
      • Santiago, Santiago Metropolitan, Chile, 7560907
        • Withdrawn
        • Centro Oncologia de Precision Universidad Mayor
  • Czechia
      • Hradec Králové, Czechia, 50005
        • Recruiting
        • University hospital Hradec Králové
      • Prague, Czechia, 10034
        • Recruiting
        • University Hospital Královské Vinohrady
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna Fakultní Nemocnice
  • France
      • Angers, France, 49933
        • Recruiting
        • Centre Hospitalier Universitaire Angers
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Louis
      • Paris, France, 755710
        • Recruiting
        • Hopital Saint-Antoine
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Poitiers
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS)
    • 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
        • Centre Hospitalier Régional Universitaire de Tours
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Recruiting
        • Nantes University Hospital
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
        • Recruiting
        • Hôpital de la Conception
    • Île-de-France Region
      • Argenteuil, Île-de-France Region, France, 95100
        • Recruiting
        • Hopital Victor Dupouy Argenteuil
      • Villejuif, Île-de-France Region, France, 94800
        • Recruiting
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charité Universitätsmedizin Berlin Campus Benjamin Franklin
      • Dresden, Germany, 01307
        • Recruiting
        • University Hospital Carl Gustav Carus
      • Kiel, Germany, 24116
        • Recruiting
        • Stadtisches Krankenhaus Kiel
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Withdrawn
        • Robert-Bosch-Krankenhaus
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • University Hospital Wurzburg
    • Gmund
      • Mutlangen, Gmund, Germany, D-73557
        • Recruiting
        • Kliniken Ostalb Stauferklinikum Schwab Gmund
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 15236
        • Recruiting
        • Clinic Frankfurt (Oder)
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Hematological Praxis Dresden
  • 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
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Ascoli Piceno, Italy, 63100
        • Recruiting
        • UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
      • Naples, Italy, 80131
        • Recruiting
        • Federico II University
      • Novara, Italy, 28100
        • Recruiting
        • AOU Maggiore della Carita-SCDU Ematologia
      • Ravenna, Italy, 48121
        • Recruiting
        • UO Ematologia Ravenna
      • Udine, Italy, 33100
        • Recruiting
        • Santa Maria della Misericordia
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale dell'Angelo - Varese
    • Forli Cesena
      • Meldola, Forli Cesena, Italy, 47014
        • Recruiting
        • Istituto Romagnolo Per Lo Studio Dei Tumori
    • Italia
      • Bologna, Italia, Italy, 40138
        • Recruiting
        • Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Recruiting
        • Pia Fondazione Panico
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Candiolo Cancer Institute, FPO, IRCCS
  • Poland
      • Katowice, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice
      • Lodz, Poland, 93-513
        • Withdrawn
        • Copernicus Memorial Hospital
      • Lublin, Poland, 20-954
        • Recruiting
        • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Warsaw, Poland, 02781
        • Withdrawn
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
    • Lower Silesian Voivodeship
      • Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
        • Recruiting
        • Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny
    • Malopolska
      • Krakow, Malopolska, Poland, 30-510
        • Recruiting
        • Pratia MCM Krakow
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
    • Wielkopolska
      • Skorzewo, Wielkopolska, Poland, 60185
        • Recruiting
        • Aidport
      • Skorzewo, Wielkopolska, Poland, 60185
        • Completed
        • Cm Pratia Poznan
  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
      • Busan, South Korea, 49201
        • Completed
        • Dong-A University Hospital
      • Daegu, South Korea, 41404
        • Withdrawn
        • Kyungpook National University Chilgok Hospital
      • Seoul, South Korea, 06591
        • Withdrawn
        • Seoul St. Mary's Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • Withdrawn
        • Center for Hematologic Malignancy
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
      • Suwon, Gyeonggi-do, South Korea, 16247
        • Recruiting
        • St. Vincents Hospital - The Catholic University of Korea
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Withdrawn
        • Jeonbuk National University Hospital
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Recruiting
        • University Hospital Vall d'Hebron
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Virgen De Las Nieves De Granada
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
      • Madrid, Spain, 28027
        • Withdrawn
        • Clinica Universidad de Navarra
      • Madrid, Spain, 28040
        • Recruiting
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, Spain, 28041
        • Recruiting
        • University Hospital & Research Institute
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro, Servicio de Hematologia
      • Madrid, Spain, 28007
        • Recruiting
        • Gregorio Maranon
      • Murcia, Spain, 30008
        • Recruiting
        • Morales Meseguer Hospital
      • Ourense, Spain, 32005
        • Recruiting
        • Complexo Hospitalario Universitario de Ourense
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca
      • Seville, Spain, 41014
        • Recruiting
        • Hospital Universitario Virgen de Valme
      • Seville, Spain, 41013
        • Recruiting
        • University Hospital Virgen del Rocio
      • Toledo, Spain, 45007
        • Withdrawn
        • Hospital General Universitario de Toledo
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario Valencia
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari and Politecnic La Fe
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Lozano Blesa
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Recruiting
        • University Hospital of Santiago de Compostela
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen De La Victoria Malaga
      • Seville, Andalusia, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07120
        • Withdrawn
        • Son Espases University Hospital
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • Cruces University Hospital (Hospital Universitario Cruces)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Withdrawn
        • Complejo Hospitalario Universitario de A Coruña
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Withdrawn
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Withdrawn
        • Hospital Universitario Central de Asturias
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern University Hospital
    • Canton of Aargau
      • Baden, Canton of Aargau, Switzerland, 5404
        • Recruiting
        • Kantonsspital Baden
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St Gallen
    • Schweiz
      • Winterthur, Schweiz, Switzerland, 8401
        • Recruiting
        • Kantonsspital Winterthur Medical Oncology
  • Taiwan
      • Changhua, Taiwan, 500-06
        • Recruiting
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung General Veterans Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Municipal Wan Fang Hospital
    • Chiayi County
      • Buzi, Chiayi County, Taiwan, 613
        • Withdrawn
        • Chang Gung Medical Foundation Chia Yi Branch
    • Guishan District
      • Taoyuan City, Guishan District, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital Linkou
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Liv Hospital Ankara
      • Istanbul, Turkey (Türkiye), 34365
        • Recruiting
        • VKV American Hopital
      • Istanbul, Turkey (Türkiye), 34418
        • Recruiting
        • Istanbul University Istanbul Faculty of Medicine
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege University
      • Kayseri, Turkey (Türkiye), 38039
        • Recruiting
        • Erciyes University
      • Sakarya, Turkey (Türkiye), 54290
        • Recruiting
        • Sakarya University Medical Faculty
      • Samsun, Turkey (Türkiye), 55239
        • Recruiting
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Zonguldak, Turkey (Türkiye), 67100
        • Recruiting
        • Zonguldak Bülent Ecevit University
    • Ankara
      • Mamak, Ankara, Turkey (Türkiye), 06620
        • Recruiting
        • Ankara University Faculty of Medicine
      • Yenimahalle, Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
    • Central Anatolia
      • Ankara, Central Anatolia, Turkey (Türkiye), 06100
        • Recruiting
        • Gazi University
    • 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
      • Romford, United Kingdom, RM7 0AG
        • Recruiting
        • Barking, Havering and Redbridge University Hospitals NHS Trust
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Withdrawn
        • Derriford Hospital and the Royal Eye Infirmary
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH77DW
        • Recruiting
        • University Hospitals Dorset
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA
      • Orange, California, United States, 92868
        • Withdrawn
        • UC Irvine Health
    • Indiana
      • Noblesville, Indiana, United States, 46062
        • Recruiting
        • Investigative Clinical Research of Indiana
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Completed
        • Hattiesburg Clinic
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mt Sinai
      • 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
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Levine Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Center for Oncology and Blood Disorders
      • Tyler, Texas, United States, 75701
        • Withdrawn
        • HOPE Cancer Center of East Texas
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute - Oncology Division
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
      • Richmond, Virginia, United States, 23219
        • Withdrawn
        • Virginia Commonwealth University
    • 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. Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
  2. Need for treatment as described in the protocol
  3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. Adequate bone marrow function and hepatic function, as described in the protocol

Key Exclusion Criteria:

  1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
  2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
  3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
  4. Treatment with any systemic anti-lymphoma therapy
  5. Infections and allergy/hypersensitivity to study drug or excipient, 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

Part 1 is a safety run-in. All participants will receive odronextamab.

In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.
Drug: Odronextamab
Administered per the protocol
Other Names:
  • REGN1979
Active Comparator: Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
Drug: Rituximab
Administered per the protocol
Other Names:
  • Rituxan
Drug: Cyclophosphamide
Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Other Names:
  • Cytoxan
Drug: Doxorubicin
Administered per the protocol as part of CHOP chemotherapy
Other Names:
  • Adriamycin
Drug: Vincristine
Administered per the protocol as part of CHOP, and CVP chemotherapy
Other Names:
  • Oncovin
Drug: Prednisone/prednisolone
Administered per the protocol as part of CVP chemotherapy
Other Names:
  • Deltasone/Omnipred
Drug: Bendamustine
Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
Other Names:
  • Treanda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of TEAEs of odronextamab
Time Frame: Up to 2 years
Part 1
Up to 2 years
Complete Response at 30 months (CR30) as assessed by independent central review
Time Frame: Up to 30 months
Part 2
Up to 30 months
Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab
Time Frame: Up to 35 days
Part 1
Up to 35 days
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab
Time Frame: Up to 2 years
Part 1
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Concentrations of odronextamab in serum
Time Frame: Up to 30 months
Part 1
Up to 30 months
Objective response as assessed by the investigator
Time Frame: Up to 30 months
Part 1
Up to 30 months
CR30 as assessed by local investigator
Time Frame: Up to 30 months
Part 2
Up to 30 months
PFS as assessed by the local investigator
Time Frame: Up to 5 years
Part 2
Up to 5 years
EFS as assessed by the local investigator
Time Frame: Up to 5 years
Part 2
Up to 5 years
Objective response assessed by local investigator
Time Frame: Up to 30 months
Part 2
Up to 30 months
Objective response assessed by independent central review
Time Frame: Up to 30 months
Part 2
Up to 30 months
DOR assessed by local investigator
Time Frame: Up to 5 years
Part 2
Up to 5 years
Odronextamab concentrations in serum during the induction period
Time Frame: Up to 30 months
Part 2
Up to 30 months
Odronextamab concentrations in serum during the maintenance period
Time Frame: Up to 30 months
Part 2
Up to 30 months
Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- 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 global health status (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
Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (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
Overall mean changes in scores of PROs, as measured by the validated instruments 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
Change in score of the GP5 item in the participant population
Time Frame: Up to 5 years
Part 2 A single item Global Population item 5 (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 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 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
Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (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 global health status (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
Progression-Free Survival (PFS) as assessed by independent central review
Time Frame: Up to 5 years
Part 2
Up to 5 years
Event-Free Survival (EFS) as assessed by independent central review
Time Frame: Up to 5 years
Part 2
Up to 5 years
Duration Of Response (DOR) assessed by independent central review
Time Frame: Up to 5 years
Part 2
Up to 5 years
Time To Next anti-lymphoma Treatment (TTNT)
Time Frame: Up to 5 years
Part 2
Up to 5 years
Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab
Time Frame: Up to 30 months
Part 1
Up to 30 months
Magnitude of ADAs to odronextamab
Time Frame: Up to 30 months
Part 1
Up to 30 months
Occurrence of ADAs to odronextamab
Time Frame: Up to 30 months
Part 2
Up to 30 months
Magnitude of ADAs to odronextamab
Time Frame: Up to 30 months
Part 2
Up to 30 months

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 12, 2023

Primary Completion (Estimated)

February 7, 2028

Study Completion (Estimated)

November 3, 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 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1979-HM-2298
  • 2022-502660-20-00 (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.

Clinical Trials on Follicular Lymphoma (FL)

Clinical Trials on Odronextamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe