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
- A Coruña, Barakaldo, Barcelona, El Palmar, Granada, Madrid, Málaga, Murcia, Ourense, Oviedo, Palma, Pamplona, Pozuelo de Alarcón, Salamanca, Santander, Santiago de Compostela, Seville, Toledo, Valencia, and Zaragoza, SpainSee the 28 sites
- Phase
- Phase 3
Where in Spain
- Complejo Hospitalario Universitario de A CoruñaA Coruña, SpainNo longer taking part
- Cruces University Hospital (Hospital Universitario Cruces)Barakaldo, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- University Hospital Vall d'HebronBarcelona, SpainTaking people
- Hospital Clínico Universitario Virgen de la ArrixacaEl Palmar, SpainNo longer taking part
- Hospital Virgen De Las Nieves De GranadaGranada, SpainTaking people
- Fundación Jiménez Díaz University HospitalMadrid, SpainTaking people
- Gregorio MaranonMadrid, SpainTaking people
- Hospital Universitario HM Sanchinarro, Servicio de HematologiaMadrid, SpainTaking people
- University Hospital & Research InstituteMadrid, SpainTaking people
- Clinica Universidad de NavarraMadrid, SpainNo longer taking part
- Hospital Universitario Virgen De La Victoria MalagaMálaga, SpainTaking people
- Morales Meseguer HospitalMurcia, SpainTaking people
- Complexo Hospitalario Universitario de OurenseOurense, SpainNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpainNo longer taking part
- Son Espases University HospitalPalma, SpainNo longer taking part
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- University Hospital of Santiago de CompostelaSantiago de Compostela, SpainTaking people
- Hospital Universitario Virgen de ValmeSeville, SpainTaking people
- Hospital Universitario Virgen MacarenaSeville, SpainTaking people
- University Hospital Virgen del RocioSeville, SpainTaking people
- Hospital General Universitario de ToledoToledo, SpainNo longer taking part
- Hospital Universitari and Politecnic La FeValencia, SpainTaking people
- Hospital Clinico Universitario ValenciaValencia, SpainNo longer taking part
- Hospital Clinico Lozano BlesaZaragoza, SpainTaking 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.