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RECRUITING
NCT06230224
PHASE3

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Official title: A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2024-02-15

Completion Date

2027-05-14

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Odronextamab

Administered by intravenous (IV) infusion

DRUG

Ifosfamide

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUG

Carboplatin

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUG

Etoposide

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUG

Rituximab

Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

DRUG

Dexamethasone

Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

DRUG

Cisplatin

Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

DRUG

Cytarabine

Administered by IV infusion, as part of the DHAP ± R salvage therapy.

DRUG

Gemcitabine

Administered by IV infusion, as part of the GDP ± R salvage therapy.

Locations (101)

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundaleu - Fundacion Para Combatir La Leucemia

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Hospital Alta Complejidad El Cruce

San Juan Bautista, Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Hospital Privado Universitario de Cordoba

Córdoba, Argentina

Liverpool Hospital

Liverpool, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Olivia Newton John Cancer Wellness & Research Centre

Heidelberg, Victoria, Australia

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, Brazil

Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

Ensino e Terapia de Inovacao Clinica Amo (Etica)

Salvador, Estado de Bahia, Brazil

Hospital Sirio Libanes Brasilia

Brasília, Federal District, Brazil

Uopeccan Hospital do Cancer de Cascavel

Cascavel, Paraná, Brazil

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Centro Gaucho Integrado

Porto Alegre, Rio Grande do Sul, Brazil

Amaral Carvalho Hospital

Jaú, São Paulo, Brazil

Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio de Janeiro, Brazil

Hospital Sirio Libanes

São Paulo, Brazil

A Beneficencia Portuguesa de Sao Paulo, Oncology House

São Paulo, Brazil

Instituto D'Or De Pesquisa e Ensino

São Paulo, Brazil

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

São Paulo, Brazil

Casa de Saude Santa Marcelina

São Paulo, Brazil

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Clinica Imbanaco

Cali, Valle del Cauca Department, Colombia

University of Pecs

Pécs, Baranya, Hungary

Debreceni Egyetem

Debrecen, Hajdú-Bihar, Hungary

Semmelweis University

Budapest, Hungary

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-Cesena, Italy

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

Aviano, Pordenone, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

AOU Maggiore della Carita

Novara, Italy

Ospedale di Circolo e Fondazione Macchi Varese

Varese, Italy

Hospital Sultanah Aminah Jhor Bahru

Johor Bahru, Johor, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Hospital Ampang

Kuala Lumpur, Selangor, Malaysia

Subang Jaya Medical Center

Subang Jaya, Selangor, Malaysia

Erasmus University Medical Center

Rotterdam, Netherlands

Coltea Clinical Hospital

Bucharest, București, Romania

Ion Chiricuta Oncology Institute

Cluj-Napoca, Cluj, Romania

National University Hospital Singapore

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea

St. Vincent Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Gachon University Gil Medical Center

Incheon, Namdong-Gu, South Korea

Dong-A University Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Yeyungnam University Medical Center

Daegu, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Asan Medical Center

Seoul, South Korea

Seoul St Marys Hospital

Seoul, South Korea

Yeouido St. Marys Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Virgen De Las Nieves De Granada

Granada, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Fundacion Jimenez Diaz University Hospital

Madrid, Spain

Clinica Universidad de Navarra- Pamplona

Pamplona, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

University Hospital Doctor Peset

Valencia, Spain

Chang Gung Medical Foundation

Chiayi City, Chianan Plain, Taiwan

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan District, Hunan Province, Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Show Chwan Memorial Hospital

Changhua, Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

Taichung General Veterans Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chulalongkorn University

Bangkok, Thailand

Sriraj Hospital

Bangkok, Thailand

Chiang Mai University

Chiang Mai, Thailand

Khon Kaen University

Khon Kaen, Thailand

Ankara University Faculty of Medicine

Mamak, Ankara, Turkey (Türkiye)

Gazi University

Ankara, Central Anatolia, Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mezitli, Mersin, Turkey (Türkiye)

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa, Turkey (Türkiye)

Sbu Dr.A.Y. Ankara Onkoloji Suam

Ankara, Turkey (Türkiye)

VKV American Hopital

Istanbul, Turkey (Türkiye)

Istanbul University

Istanbul, Turkey (Türkiye)

Ege University

Izmir, Turkey (Türkiye)

Sakarya University Medical Faculty

Sakarya, Turkey (Türkiye)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)