Tests odronextamab against standard treatment in adults with aggressive B-cell lymphoma
Compares odronextamab with standard treatment in adults with previously treated aggressive lymphoma.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Antwerp, Brussels, Gent, and Yvoir, BelgiumSee the 4 sites
- Phase
- Phase 3
Where in Belgium
- Het Ziekenhuisnetwerk AntwerpenAntwerp, BelgiumNo longer taking part
- Institut Jules BordetBrussels, BelgiumNo longer taking part
- Universitair Ziekenhuis GentGent, BelgiumNo longer taking part
- Chu Ucl NamurYvoir, BelgiumNo longer taking part
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 Inc.
- Trial code
- NCT06230224EU 2022-502783-21-00
- Record updated
- 25 May 2026
- Original description
To compare the efficacy, as defined by EFS, in participants treated with odronextamab versus participants treated with Standard of Care (SOC)Read full original descriptionShow less
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)
To compare the efficacy, as defined by EFS, in participants treated with odronextamab versus participants treated with Standard of Care (SOC)
Inclusion: 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; Other protocol defined inclusion criteria apply.
Exclusion: Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol; History of or current relevant CNS pathology, as described in the protocol; A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated; Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol; Allergy/hypersensitivity to study drug, or excipients; Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol; Other protocol defined exclusion criteria apply.