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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)
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Sanatorio Allende
Córdoba, Argentina
Hospital Privado Universitario de Cordoba
Córdoba, Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Start Date
February 15, 2024
Primary Completion Date
May 14, 2027
Completion Date
May 14, 2027
Last Updated
February 6, 2026
216
ESTIMATED participants
Odronextamab
DRUG
Ifosfamide
DRUG
Carboplatin
DRUG
Etoposide
DRUG
Rituximab
DRUG
Dexamethasone
DRUG
Cisplatin
DRUG
Cytarabine
DRUG
Gemcitabine
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT05098613
NCT05397496
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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