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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
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
Conditions
Interventions
Odronextamab
Administered by intravenous (IV) infusion
Ifosfamide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Carboplatin
Administered by IV infusion, as part of the ICE ± R salvage therapy
Etoposide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Rituximab
Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.
Dexamethasone
Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.
Cisplatin
Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.
Cytarabine
Administered by IV infusion, as part of the DHAP ± R salvage therapy.
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)