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)

Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

• 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 \[MRI\])

• Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol

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

• Adequate hematologic and organ function.

Locations
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Fundaleu - Fundacion Para Combatir La Leucemia
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Britanico de Buenos Aires
RECRUITING
Ciudad Autonoma De Buenos Aires
Instituto Alexander Fleming
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Italiano de La Plata
RECRUITING
La Plata
Australia
Olivia Newton John Cancer Wellness & Research Centre
RECRUITING
Heidelberg
Royal Hobart Hospital
RECRUITING
Hobart
Liverpool Hospital
WITHDRAWN
Liverpool
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Brazil
Hospital Sirio Libanes Brasilia
RECRUITING
Brasília
Uopeccan Hospital do Cancer de Cascavel
RECRUITING
Cascavel
Hospital Erasto Gaertner
RECRUITING
Curitiba
Amaral Carvalho Hospital
RECRUITING
Jaú
Centro Gaucho Integrado
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
RECRUITING
Rio De Janeiro
Ensino e Terapia de Inovacao Clinica Amo (Etica)
RECRUITING
Salvador
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
RECRUITING
Salvador
Hospital Sao Rafael
RECRUITING
Salvador
A Beneficencia Portuguesa de Sao Paulo, Oncology House
RECRUITING
São Paulo
Casa de Saude Santa Marcelina
RECRUITING
São Paulo
Hospital Sirio Libanes
RECRUITING
São Paulo
Instituto D'Or De Pesquisa e Ensino
RECRUITING
São Paulo
Chile
Clinica Alemana de Santiago
RECRUITING
Santiago
Colombia
Clinica Imbanaco
RECRUITING
Cali
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Hungary
University of Pecs
RECRUITING
Pécs
Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
WITHDRAWN
Aviano
Azienda Ospedaliera Spedali Civili di Brescia
WITHDRAWN
Brescia
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
WITHDRAWN
Meldola
AOU Maggiore della Carita
WITHDRAWN
Novara
Ospedale di Circolo e Fondazione Macchi Varese
WITHDRAWN
Varese
Malaysia
Hospital Sultanah Aminah Jhor Bahru
RECRUITING
Johor Bahru
Hospital Queen Elizabeth
RECRUITING
Kota Kinabalu
Hospital Ampang
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Subang Jaya Medical Center
RECRUITING
Subang Jaya
Netherlands
Erasmus University Medical Center
WITHDRAWN
Rotterdam
Republic of Korea
Dong-A University Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Yeyungnam University Medical Center
WITHDRAWN
Daegu
National Cancer Center
RECRUITING
Gyeonggi-do
Gachon University Gil Medical Center
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Asan Medical Center
RECRUITING
Seoul
Seoul St Marys Hospital
RECRUITING
Seoul
Yeouido St. Marys Hospital
RECRUITING
Seoul
St. Vincent Hospital - The Catholic University of Korea
RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Romania
Ion Chiricuta Oncology Institute
RECRUITING
Cluj-napoca
Singapore
National University Hospital Singapore
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Spain
Hospital Virgen De Las Nieves De Granada
WITHDRAWN
Granada
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
Fundacion Jimenez Diaz University Hospital
WITHDRAWN
Madrid
Hospital Universitario Infanta Leonor
WITHDRAWN
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitari Son Espases
COMPLETED
Palma
Clinica Universidad de Navarra- Pamplona
RECRUITING
Pamplona
Hospital Universitario Quironsalud Madrid
WITHDRAWN
Pozuelo De Alarcón
Hospital Universitario Virgen del Rocio
WITHDRAWN
Seville
Hospital Universitari Mutua Terrassa
WITHDRAWN
Terrassa
Instituto Valenciano de Oncologia
COMPLETED
Valencia
University Hospital Doctor Peset
WITHDRAWN
Valencia
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Show Chwan Memorial Hospital
RECRUITING
Changhua
Chang Gung Medical Foundation
RECRUITING
Chiayi City
Chang Gung Memorial Hospital Kaohsiung
RECRUITING
Kaohsiung City
Kaohsiung Medical University Hospital
RECRUITING
Kaohsiung City
Taipei Medical University - Shuang Ho Hospital
RECRUITING
New Taipei City
Taichung General Veterans Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch
RECRUITING
Taoyuan District
Thailand
Chulalongkorn University
RECRUITING
Bangkok
Sriraj Hospital
RECRUITING
Bangkok
Chiang Mai University
RECRUITING
Chiang Mai
Khon Kaen University
RECRUITING
Khon Kaen
Turkey
Gazi University
RECRUITING
Ankara
Sbu Dr.A.Y. Ankara Onkoloji Suam
RECRUITING
Ankara
Istanbul University
RECRUITING
Istanbul
Ege University
RECRUITING
Izmir
Ankara University Faculty of Medicine
RECRUITING
Mamak
VM Medical Park Mersin Hospital
RECRUITING
Mezitli
Sakarya University Medical Faculty
RECRUITING
Sakarya
Ondokuz Mayıs University
RECRUITING
Samsun
Tekirdag Namik Kemal University Hospital
RECRUITING
Tekirdağ
Zonguldak Bulent Ecevit University
RECRUITING
Zonguldak
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2027-05-14
Participants
Target number of participants: 216
Treatments
Experimental: Odronextamab
Participants will receive odronextamab monotherapy.
Active_comparator: Standard Of Care
Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab \[ICE ± R\], or dexamethasone, cisplatin, cytarabine ± rituximab \[DHAP ± R\], or gemcitabine, dexamethasone, cisplatin ± rituximab \[GDP ± R\]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR).
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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