A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Last updated: March 20, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma, B-cell

Lymphoma

Anger

Treatment

Ifosfamide

Etoposide

Dexamethasone

Clinical Study ID

NCT06230224
R1979-HM-2299
2022-502783-21-00
  • 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 patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug versus Standard of Care (SOC)

  • 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)

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically proven aggressive B-NHL, as described in the protocol. Availabilityof tumor tissue for submission to central laboratory is required for studyenrollment. Archival tumor tissue for histological assessment prior to enrollment isallowed

  2. Have primary refractory or relapse 12 months or less (≤) from initiation offrontline therapy Only patients who received 1 prior line of therapy containing ananti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed forenrollment

  3. Have measurable disease with at least one nodal lesion with longer diameter (LDi)greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm,documented by diagnostic imaging (computed tomography [CT] or magnetic resonanceimaging [MRI])

  4. Intent to proceed to autologous stem cell transplant (ASCT), as described in theprotocol

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

  6. Adequate hematologic and organ function.

Exclusion

Key Exclusion Criteria:

  1. Primary central nervous system (CNS) lymphoma or known involvement by non-primaryCNS NHL, as described in the protocol

  2. History of or current relevant CNS pathology, as described in the protocol

  3. A malignancy other than NHL unless the participant is adequately and definitivelytreated and is cancer free for at least 3 years, with the exception of localizedprostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanomaskin cancer that was definitively treated

  4. Any other significant active disease or medical condition that could interfere withthe conduct of the study or put the participant at significant risk, as described inthe protocol

  5. Wash-out period from prior anti-lymphoma treatments and infections, as described inthe protocol

  6. Allergy/hypersensitivity to study drug, or excipients.

NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Design

Total Participants: 216
Treatment Group(s): 9
Primary Treatment: Ifosfamide
Phase: 3
Study Start date:
February 15, 2024
Estimated Completion Date:
May 14, 2027

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Austin Cancer Clinical Trails

    Heidelberg, Victoria VIC 3084
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria VIC 3084
    Australia

    Active - Recruiting

  • Olivia Newton John Cancer Wellness & Research Centre

    Heidelberg, Victoria VIC 3084
    Australia

    Active - Recruiting

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

    Meldola, Forli Cesena 47014
    Italy

    Site Not Available

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

    Meldola (fc), Forli Cesena 47014
    Italy

    Site Not Available

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

    Meldola, Forli-Cesena 47014
    Italy

    Site Not Available

  • Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute

    Aviano, Province Of Pordenone 33081
    Italy

    Site Not Available

  • Azienda Ospedaliera (ASST) Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • AOU Maggiore della Carita

    Novara, 28100
    Italy

    Site Not Available

  • Ospedale Maggiore Della Carita

    Novara, 28100
    Italy

    Active - Recruiting

  • ASST Settelaghi, Ospedale di circolo e Fondazione macchi

    Varese, 21100
    Italy

    Active - Recruiting

  • Ospedale di Circolo e Fondazione Macchi Varese

    Varese, 21100
    Italy

    Site Not Available

  • St. Vincent Hospital, The Catholic University of Korea

    Suwon-si, Gyeonggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon-si, Gyeonggi-do 16247
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu 21565
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center (AMC)

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital (PNUH)

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Yeyungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju, 54907
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • College of Medicine - Catholic Research Institute of Medical Science

    Seoul, 137-701
    Korea, Republic of

    Active - Recruiting

  • Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, 137-701
    Korea, Republic of

    Active - Recruiting

  • Yeouido St. Marys Hospital

    Seoul, 07345
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

  • Hospital Sultanah Aminah Jhor Bahru

    Johor Bahru, Johor 80100
    Malaysia

    Active - Recruiting

  • Hospital Sultanah Aminah Johor Bahru

    Johor Bahru, Johor 80100
    Malaysia

    Active - Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah 88586
    Malaysia

    Active - Recruiting

  • Hospital Queen Elizabeth II

    Kota Kinabalu, Sabah 88586
    Malaysia

    Active - Recruiting

  • Ampang Hospital

    Ampang, Selangor 68000
    Malaysia

    Site Not Available

  • Hospital Ampang

    Kuala Lumpur, Selangor 68000
    Malaysia

    Active - Recruiting

  • Subang Jaya Medical Center

    Subang Jaya, Selangor 47500
    Malaysia

    Active - Recruiting

  • Subang Jaya Medical Centre

    Subang Jaya, Selangor 47500
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
    Malaysia

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam, 1079NG
    Netherlands

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • National University Hospital Singapore

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, Andalusia 41013
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma, Balearic Islands 07120
    Spain

    Site Not Available

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona 08021
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Son Espases

    Palma, Palma De Mallorca 07120
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Virgen De Las Nieves De Granada

    Granada, 18014
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Sede Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Instituto Valenciano de Oncologia

    Valencia, 46009
    Spain

    Completed

  • University Hospital Doctor Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Chang Gung Medical Foundation

    Chiayi City, Chianan Plain 613
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, Toayuan District 333
    Taiwan

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua City, 500-06
    Taiwan

    Active - Recruiting

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 613
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    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-Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • Taichung General Veterans Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Cheng-Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei City, 10002
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei City, 114
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital- Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Chulalongkorn University

    Bangkok, 10330
    Thailand

    Active - Recruiting

  • Siriraj Institute

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Sriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Gazi University

    Ankara, Central Anatolia 06100
    Turkey

    Active - Recruiting

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin 33200
    Turkey

    Active - Recruiting

  • Sakarya University Training and Research Hospital

    Serdivan, Sakarya 54290
    Turkey

    Site Not Available

  • Namik Kemal Universitesi

    Tekirdag, Suleymanpasa 59100
    Turkey

    Active - Recruiting

  • Tekirdag Namik Kemal University Hospital

    Tekirdag, Suleymanpasa 59100
    Turkey

    Active - Recruiting

  • Ankara Research Hospital

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Sbu Dr.A.Y. Ankara Onkoloji Suam

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Ege University

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Ege University Hospital

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Sakarya University Medical Faculty

    Sakarya, 54290
    Turkey

    Active - Recruiting

  • Sakarya Universty Medical Faculty

    Sakarya, 54290
    Turkey

    Active - Recruiting

  • Ondokuz Mayis Universitesi (OMU) Tip Fakultesi

    Samsun,
    Turkey

    Active - Recruiting

  • Ondokuz Mayıs University

    Samsun, 55270
    Turkey

    Active - Recruiting

  • Zonguldak Bulent Ecevit Univesity

    Zonguldak, 67600
    Turkey

    Active - Recruiting

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