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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502660-20-00
Acronym
R1979-HM-2298
Enrollment
255
Registered
2023-10-05
Start date
2024-01-23
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Follicular lymphoma

Brief summary

Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab, Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab, Part 1: Severity of TEAEs of odronextamab, Part 2: CR30 as assessed by independent central review

Detailed description

Part 1: Concentrations of odronextamab in serum, Part 1:Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Part 1: Magnitude of ADAs to odronextamab over the study duration, Part 1: Objective response as assessed by the investigator, Part 2: Progression-free survival (PFS) as assessed by independent central review, Part 2: Event-free survival (EFS) as assessed by independent central review, Part 2: OS, Part 2: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)], Part 2: CR30 as assessed by local investigator, Part 2: PFS as assessed by local investigator, Part 2: EFS as assessed by local investigator, Part 2: Objective response assessed by local investigator, Part 2: Objective response assessed by independent central review, Part 2: Duration of response (DOR) assessed by independent central review, Part 2: DOR assessed by local investigator, Part 2: Time to next anti-lymphoma treatment (TTNT), Part 2: Incidence of TEAEs, Part 2: Severity of TEAEs, Part 2: Odronextamab concentrations in serum during the induction period, Part 2: Odronextamab concentrations in serum during the maintenance period, Part 2: Incidence of ADAs to odronextamab over the study duration, Part 2: Magnitude of ADAs to odronextamab over the study duration, Part 2: Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30, Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS), Part 2: Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L), Part 2: Change in PGIS and PGIC, Part 2: Change in score of GP5 item in the participant population

Interventions

DRUGCYCLOPHOSPHAMIDE
DRUGBENDAMUSTINE HYDROCHLORIDE
DRUGPREDNISONE
DRUGDOXORUBICIN HYDROCHLORIDE
DRUGOdronextamab
DRUGTruxima 500 mg concentrate for solution for infusion
DRUGPREDNISOLONE
DRUGVINCRISTINE SULFATE

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Incidence of dose-limiting toxicities (DLTs) for odronextamab, Part 1: Incidence of treatment-emergent adverse events (TEAEs) of odronextamab, Part 1: Severity of TEAEs of odronextamab, Part 2: CR30 as assessed by independent central review

Secondary

MeasureTime frame
Part 1: Concentrations of odronextamab in serum, Part 1:Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration, Part 1: Magnitude of ADAs to odronextamab over the study duration, Part 1: Objective response as assessed by the investigator, Part 2: Progression-free survival (PFS) as assessed by independent central review, Part 2: Event-free survival (EFS) as assessed by independent central review, Part 2: OS, Part 2: Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)], Part 2: CR30 as assessed by local investigator, Part 2: PFS as assessed by local investigator, Part 2: EFS as assessed by local investigator, Part 2: Objective response assessed by local investigator, Part 2: Objective response assessed by independent central review, Part 2: Duration of response (DOR) assessed by independent central review, Part 2: DOR assessed by local investigator, Part 2: Ti

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026