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New hope for tough lymphoma: experimental drug faces standard care in phase 3 showdown

NCT ID NCT06230224

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug, odronextamab, in people with aggressive B-cell non-Hodgkin lymphoma that has come back or no longer responds to treatment. About 216 participants will receive either the new drug or standard therapy to compare safety, effectiveness, and quality of life. The goal is to see if odronextamab can better control the cancer and delay its progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

216 people

The number who actually took part.

Started

Feb 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 2. Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment 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 resonance imaging \[MRI\]) 4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6. Adequate hematologic and organ function. Key Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS 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 definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated 4. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol 5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol 6. Allergy/hypersensitivity to study drug, or excipients. NOTE: Other protocol defined inclusion / exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell neoplasm B-cell non-Hodgkin lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell non-Hodgkin lymphoma (B-NHL)

Contacts and locations

Locations

  • A Beneficencia Portuguesa de Sao Paulo, Oncology House

    São Paulo, 01321000, Brazil

  • Amaral Carvalho Hospital

    Jaú, São Paulo, 17210-080, Brazil

  • Ankara University Faculty of Medicine

    Mamak, Ankara, 06620, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070, Brazil

  • Centro Gaucho Integrado

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, Hunan Province, 33305, Taiwan

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301, Taiwan

  • Changhua Christian Hospital

    Changhua, 500-06, Taiwan

  • Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Chulalongkorn University

    Bangkok, 10330, Thailand

  • Clinica Alemana de Santiago

    Santiago, Santiago Metropolitan, 7650620, Chile

  • Clinica Imbanaco

    Cali, Valle del Cauca Department, 760042, Colombia

  • Clinica Universidad de Navarra- Pamplona

    Pamplona, 31008, Spain

  • Coltea Clinical Hospital

    Bucharest, Bucharest, 030141, Romania

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Ege University

    Izmir, 35100, Turkey (Türkiye)

  • Ensino e Terapia de Inovacao Clinica Amo (Etica)

    Salvador, Estado de Bahia, 41950-640, Brazil

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan, 7500921, Chile

  • Fundaleu - Fundacion Para Combatir La Leucemia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAN, Argentina

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565, South Korea

  • Gazi University

    Ankara, Central Anatolia, 06100, Turkey (Türkiye)

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1118, Argentina

  • Hospital Alta Complejidad El Cruce

    San Juan Bautista, Buenos Aires, B1888AAE, Argentina

  • Hospital Ampang

    Kuala Lumpur, Selangor, 68000, Malaysia

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1280, Argentina

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900AUR, Argentina

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia, 050034, Colombia

  • Hospital Privado Universitario de Cordoba

    Córdoba, X5016KEH, Argentina

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410, Brazil

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 40285-000, Brazil

  • Hospital Sirio Libanes

    São Paulo, 01308-050, Brazil

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730, Brazil

  • Hospital Sultanah Aminah Jhor Bahru

    Johor Bahru, Johor, 80100, Malaysia

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo

    São Paulo, 05403-000, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Instituto Alexander Fleming

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426, Argentina

  • Instituto D'Or De Pesquisa e Ensino

    São Paulo, 04501-000, Brazil

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva

    Rio de Janeiro, 20231050, Brazil

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Ion Chiricuta Oncology Institute

    Cluj-Napoca, Cluj, 400015, Romania

  • Istanbul University

    Istanbul, 34418, Turkey (Türkiye)

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Khon Kaen University

    Khon Kaen, 40002, Thailand

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital Singapore

    Singapore, 119074, Singapore

  • Olivia Newton John Cancer Wellness & Research Centre

    Heidelberg, Victoria, 3084, Australia

  • Ondokuz Mayıs University

    Samsun, 55270, Turkey (Türkiye)

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Sakarya University Medical Faculty

    Sakarya, 54290, Turkey (Türkiye)

  • Sanatorio Allende

    Córdoba, X5000JHQ, Argentina

  • Sbu Dr.A.Y. Ankara Onkoloji Suam

    Ankara, 06100, Turkey (Türkiye)

  • Semmelweis University

    Budapest, 1088, Hungary

  • Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • Show Chwan Memorial Hospital

    Changhua, 50008, Taiwan

  • Sriraj Hospital

    Bangkok, 10700, Thailand

  • St. Vincent Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247, South Korea

  • Subang Jaya Medical Center

    Subang Jaya, Selangor, 47500, Malaysia

  • Taichung General Veterans Hospital

    Taichung, 40705, Taiwan

  • Tekirdag Namik Kemal University Hospital

    Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • University of Pecs

    Pécs, Baranya, 7624, Hungary

  • Uopeccan Hospital do Cancer de Cascavel

    Cascavel, Paraná, 85806-300, Brazil

  • VKV American Hopital

    Istanbul, 34365, Turkey (Türkiye)

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin, 33200, Turkey (Türkiye)

  • Yeouido St. Marys Hospital

    Seoul, 07345, South Korea

  • Zonguldak Bulent Ecevit University

    Zonguldak, 67600, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.