A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Last updated: April 22, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

Rituximab

Cyclophosphamide

Odronextamab

Clinical Study ID

NCT06097364
R1979-ONC-2075
2022-502113-28-00
  • Ages > 18
  • All Genders

Study Summary

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study.

This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled).

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 to be used in Part 2 of the study.

The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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)

  • The impact from the study drug on quality-of-life and ability to complete routine daily activities

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a,stage II bulky or stage III / IV

  2. For Part 1A: previously untreated participants who have Follicular LymphomaInternational Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL

  3. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5

  4. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5

  5. Have measurable disease on cross sectional imaging documented by diagnostic computedtomography [CT], or magnetic resonance imaging [MRI] imaging, as described in theprotocol

  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  7. Adequate bone marrow and hepatic function.

Exclusion

Key Exclusion Criteria:

  1. Participants with central nervous system lymphoma or leptomeningeal lymphoma

  2. Participants with histological evidence of transformation to a high-grade or diffuselarge B-cell lymphoma

  3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma),grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocyticlymphoma

  4. Recent major surgery and history or organ transplantation

  5. A malignancy other than NHL unless the participant is adequately and definitivelytreated and any other significant active disease or medical condition that couldinterfere with the conduct of the study or put the participant at significant risk,as described in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Total Participants: 733
Treatment Group(s): 6
Primary Treatment: Rituximab
Phase: 3
Study Start date:
November 14, 2023
Estimated Completion Date:
July 29, 2029

Connect with a study center

  • Liverpool Hopsital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Karl Landsteiner University Hospital St. Poelten

    Saint Poelten, Lower Austria 3100
    Austria

    Active - Recruiting

  • Medical University of Graz

    Graz, Styria 8036
    Austria

    Active - Recruiting

  • Landeskrankenhaus Hochsteiermark

    Leoben, Styria 8700
    Austria

    Active - Recruiting

  • Kepler University Hospital

    Linz, Upper Austria 4020
    Austria

    Active - Recruiting

  • Innsbruck Medical University

    Innsbruck, A-6020
    Austria

    Active - Recruiting

  • University Hospital Ghent

    Ghent, East Flanders 9000
    Belgium

    Site Not Available

  • Vzw - Vitaz

    Sint-Niklaas, East Flanders 9100
    Belgium

    Site Not Available

  • CHR Verviers

    Verviers, Liege 4000
    Belgium

    Site Not Available

  • Verenigde Ziekenhuizen van Waas en Durme

    Sint Niklaas, Oost Vlaanderen 9100
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Algemeen Ziekenhuis St Jan Brugge Oostende Av

    Bruges, West Flanders 8000
    Belgium

    Active - Recruiting

  • AZ Groeninge

    Kortrijk, West Flanders 8500
    Belgium

    Active - Recruiting

  • Hopital Universitaire de Bruxelles - Site Bordet

    Brussels, 1000
    Belgium

    Active - Recruiting

  • Institut Jules Bordet

    Brussels, 1000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Regional de la Citadelle

    Liege, 4000
    Belgium

    Active - Recruiting

  • Hospital Clinico Universidad de Los Andes

    Santiago, Las Condes 7620157
    Chile

    Active - Recruiting

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Region Metropolitana 7560907
    Chile

    Active - Recruiting

  • Inmunocel

    Santiago, Region Metropolitana 7580206
    Chile

    Active - Recruiting

  • Pontificia Universidad Catolica de Chile

    Santiago, Region Metropolitana 7550000
    Chile

    Active - Recruiting

  • Immunocel

    Santiago, Santiago Metropolitan Region 7580206
    Chile

    Active - Recruiting

  • Clinica Universidad de los Andes

    Santiago, 7620157
    Chile

    Active - Recruiting

  • University Hospital Hradec Kralove

    Hradec Kralove, North Central Czech Republic 50005
    Czechia

    Active - Recruiting

  • Cannes Hospital (Centre Hospitalier Cannes Simone Veil)

    Cannes, Alpes Maritimes 06400
    France

    Active - Recruiting

  • CHRU de Tours

    Tours, Centre Val De Loire 37044
    France

    Active - Recruiting

  • Institut de Cancerologie du Gard

    Nimes, Gard 30029
    France

    Active - Recruiting

  • Hopital Victor Dupouy Argenteuil

    Argenteuil, Ile De France 95100
    France

    Active - Recruiting

  • Centre Hospitalier de Mont-de-Marsan

    Mont de Marsan, Nouvelle Aquitaine 40024
    France

    Active - Recruiting

  • Nantes University Hospital

    Nantes, Pays De La Loire 44093
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043
    France

    Active - Recruiting

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, 43012
    France

    Active - Recruiting

  • Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)

    Lens, 62300
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hopital Haut Leveque

    Pessac, 33600
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque

    Pessac, 33600
    France

    Active - Recruiting

  • Centre Hospitalier de Saint Nazaire

    Saint Nazaire, 44600
    France

    Active - Recruiting

  • CHU de Saint-Etienne

    Saint-Etienne, 42055
    France

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9103102
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 91200
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Active - Recruiting

  • Assuta Medical Centers

    Tel Aviv, 6971028
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Universita degli Studi di Napoli Federico II

    Naples, Campania 80128
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria di Modena

    Modena, Emilia-Romagna 41124
    Italy

    Active - Recruiting

  • Azienda Unita Sanitaria Locale

    Ravenna, Emilia-Romagna 48121
    Italy

    Active - Recruiting

  • Azienda Unità Sanitaria Locale IRCCS Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna 42123
    Italy

    Active - Recruiting

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

    Meldola, Forli Cesena 47014
    Italy

    Active - Recruiting

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

    Meldola (fc), Forli Cesena 47014
    Italy

    Site Not Available

  • Instituto Scientifico Romagnolo

    Meldola, Forli-Cesena 47014
    Italy

    Site Not Available

  • IEO Istituo Europeo di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • A.O.U. di Modena

    Modena, 41124
    Italy

    Active - Recruiting

  • Federico II University

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia, 06132
    Italy

    Active - Recruiting

  • University of Pisa, Section of Hematology

    Pisa, 56126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Regionale San Carlo

    Potenza, 85100
    Italy

    Active - Recruiting

  • UO Ematologia Ravenna

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100
    Italy

    Active - Recruiting

  • Malopolskie Centrum Medyczne SC

    Krakow, Malopolskie 30-510
    Poland

    Active - Recruiting

  • Matopolskie Centrum Medyczne S.C.

    Krakow, Malopolskie 30-510
    Poland

    Active - Recruiting

  • Aidport

    Skorzewo, Wielkopolska 60185
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki Nr2 Bydgoszcz

    Bydgoszcz, 85-168
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Active - Recruiting

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

    Gdansk, 80-952
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

    Lodz, 93-513
    Poland

    Active - Recruiting

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

    Lublin, 20-954
    Poland

    Active - Recruiting

  • Szpital Szpecjalistyczny w Walbrzychu

    Walbrzych, 58-300
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

    Warszawa, 02781
    Poland

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, Andalusia 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturas 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Central De Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Consorci Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona 08290
    Spain

    Active - Recruiting

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell, Barcelona 08290
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital General Universitario Doctor Balmis Alicante

    Alicante, Comunidad Valenciana 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Sede Pamplona

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Sede Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hosptial Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense, 32005
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra- Pamplona

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital General Universitario de Toledo

    Toledo, 45007
    Spain

    Site Not Available

  • Hospital Universitario de Toledo

    Toledo, 45007
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncologia

    Valencia, 46009
    Spain

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Kaohsiung 833401
    Taiwan

    Active - Recruiting

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, New Taipei 23561
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301
    Taiwan

    Active - Recruiting

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • Taipei Medical University Multipal Wan Fang University

    Taipei, 11696
    Taiwan

    Active - Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei, 11696
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei City, 114
    Taiwan

    Active - Recruiting

  • Chulalongkorn University

    Bangkok, Krung Thep Maha Nakhon [Bangko] 10330
    Thailand

    Active - Recruiting

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Srinagrind Hopsital

    Khon Kaen, 40000
    Thailand

    Active - Recruiting

  • Srinagrind Hospital

    Khon Kaen, 40000
    Thailand

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Yenimahalle, Ankara 06200
    Turkey

    Active - Recruiting

  • Gazi University

    Ankara, Central Anatolia 06100
    Turkey

    Active - Recruiting

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin 33200
    Turkey

    Active - Recruiting

  • Sakayra University Training and Research Hospital

    Adapazari, Sakarya 54290
    Turkey

    Site Not Available

  • Sakarya University

    Sakarya, Serdivan 54050
    Turkey

    Active - Recruiting

  • Tekirdag Namik Kemal University Hospital

    Tekirdag, Suleymanpasa 59100
    Turkey

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Liv Hospital

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Liv Hospital Ankara

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Istanbul University

    Istanbul, 34418
    Turkey

    Active - Recruiting

  • VKV American Hopital

    Istanbul, 34365
    Turkey

    Active - Recruiting

  • VKV American Hospital

    Istanbul, 34365
    Turkey

    Active - Recruiting

  • Erciyes University

    Kayseri, 38030
    Turkey

    Active - Recruiting

  • Erci̇yes Uni̇versi̇ty

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Ondokuz Mayis University

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Ondokuz Mayıs University

    Samsun, 55270
    Turkey

    Active - Recruiting

  • Zonguldak Bulent Ecevit University

    Zonguldak, 67100
    Turkey

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeenshire AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Royal Cornwall Hospital

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Active - Recruiting

  • Royal Cornwall Hospital NHS Trust

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Active - Recruiting

  • The Hillingdon Hospitals NHS Foundation Trust

    Uxbridge, London UB8 3NN
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham, West Midlands B15 2SY
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands B15 2SY
    United Kingdom

    Active - Recruiting

  • NHS Grampian: Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Investigative Clinical Research of Indiana

    Noblesville, Indiana 46062
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Clinical Research Alliance Inc

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Clinical Research Alliance, Inc.

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Center for Oncology and Blood Disorders

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Community Cancer Trials of Utah

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Prohealth Care Inc

    Waukesha, Wisconsin 53188
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.