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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502783-21-00
Acronym
R1979-HM-2299
Enrollment
132
Registered
2023-09-11
Start date
2024-02-20
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Non-Hodgkin's Lymphoma

Brief summary

Event-free survival (EFS) as assessed by independent central review (ICR)

Detailed description

Progression free survival (PFS) as assessed by ICR, Best overall response (BOR) as assessed by ICR, Overall survival (OS), Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EFS as assessed by local investigator, PFS as assessed by local investigator, BOR as assessed by local investigator, Complete response (CR) assessed by ICR and local investigator, Duration of response (DOR) assessed by ICR and local investigator, Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Odronextamab concentrations in serum, Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Titers of ADAs to odronextamab over the study duration, Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration, Measurable residual disease (MRD) status, Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30, Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS), Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L), Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire

Interventions

DRUGGEMCITABINE
DRUGRITUXIMAB
DRUGOdronextamab
DRUGCYTARABINE
DRUGETOPOSIDE
DRUGCARBOPLATIN
DRUGDEXAMETHASONE
DRUGIFOSFAMIDE
DRUGCISPLATIN

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Event-free survival (EFS) as assessed by independent central review (ICR)

Secondary

MeasureTime frame
Progression free survival (PFS) as assessed by ICR, Best overall response (BOR) as assessed by ICR, Overall survival (OS), Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30), EFS as assessed by local investigator, PFS as assessed by local investigator, BOR as assessed by local investigator, Complete response (CR) assessed by ICR and local investigator, Duration of response (DOR) assessed by ICR and local investigator, Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Odronextamab concentrations in serum, Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Titers of ADAs to odronextamab over the study duration, Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration, Measurable residual disease (MRD) status, Overall change in patient-reported outcomes

Countries

Austria, Belgium, Czechia, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026