Odronextamab Compared With Standard Treatment for Untreated Follicular Lymphoma
Tests odronextamab against standard treatment in adults with untreated follicular lymphoma.
Plain-language title generated from the registry record
Registry title: A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
Key facts
- Where
- Barretos, Belo Horizonte, Brasília, Jaú, Joinville, Lages, Natal, Passo Fundo, Porto Alegre, Ribeirão Preto, Rio de Janeiro, Salvador, and São Paulo, BrazilSee the 17 sites
- Phase
- Phase 3
Where in Brazil
- Fundacao Pio XII - Hospital de AmorBarretos, BrazilTaking people
- Instituto Mario Pena de Ensino Pesquisa e InovacaoBelo Horizonte, BrazilTaking people
- Instituto DOr de Pesquisa e Ensino Df StarBrasília, BrazilTaking people
- Amaral Carvalho HospitalJaú, BrazilTaking people
- Centro de Hematologia e OncologiaJoinville, BrazilTaking people
- Animi Unidade de Tratamento Oncologico LtdaLages, BrazilTaking people
- Liga Norte Riograndense Contra o CancerNatal, BrazilTaking people
- Instituto do Cancer em Hospital Sao Vicente de PauloPasso Fundo, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao PauloRibeirão Preto, BrazilTaking people
- Instituto AmericasRio de Janeiro, BrazilTaking people
- Instituto Nacional de Cancer Jose Alencar Gomes da SilvaRio de Janeiro, BrazilNo longer taking part
- Ensino e Terapia de Inovação Clínica AMO - ETICASalvador, BrazilTaking people
- AC Camargo Cancer CenterSão Paulo, BrazilTaking people
- Casa de Saude Santa MarcelinaSão Paulo, BrazilTaking people
- Clinical Hospital of Medicine School at Sao Paulo UniversitySão Paulo, BrazilTaking people
- Hospital Alemão Oswaldo CruzSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06091254EU 2022-502660-20-00
- Record updated
- 6 October 2026
- Original description
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).Read full original descriptionShow less
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.
The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug * 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) * How the study drug affects quality of life and ability to complete routine daily activities.
Inclusion: Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV; Need for treatment as described in the protocol; Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Adequate bone marrow function and hepatic function, as described in the protocol.
Exclusion: Treatment with any systemic anti-lymphoma therapy; Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol; NOTE: Other protocol defined inclusion/exclusion criteria apply; Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma; Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma; Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma.