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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

Study acronym: OLYMPIA-1
StatusRecruiting
PhasePhase 3
Started2023-12-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v34
Study sites190 entries, revised
St Vincent'sVincents Hospital - Melbourne
2026-08-07
Study Status, Contacts/Locations v33
Study sitesdetails revised at 15 of 190 sites
2026-06-22
Study Status, Contacts/Locations v32
Study sites190 entries, revised
Irccs Aou Di Bologna - Policlinico Di Sant'Orsolaorsola Malpighi
2026-05-18
Study Status, Contacts/Locations v31
Study sites190 entries, revised
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
2026-03-09
Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v30
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2028-02-19→2028-02-07
Completion date2031-11-06→2029-11-03
Enrollment target462→822
Study sites187→190
Secondary endpoints28 entries, revised
IncidenceOccurrence of Anti-Drug Antibodies (ADAs) to odronextamab over the study duration Magnitude of ADAs to odronextamab over the study duration IncidenceOccurrence of ADAs to odronextamab over the study duration Magnitude of ADAs to odronextamab over the study duration
Study title+21 characters
[...] Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
Show 29 earlier versions
2025-09-26
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v29
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2029-04-04→2028-02-19
Completion date2029-04-04→2031-11-06
Enrollment targetestimated 478→confirmed 462
Eligibility criteria+60 characters
[...] us of 0-2 Adequate bone marrow function and hepatic function, as described in the protocol Key Exclusion Criteria: Central Nervous System (CNS) lympho [...] ions and allergy/hypersensitivity to study drug or excipient, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply
Secondary endpoints31 to 28 entries
Incidence of antiAnti-drugDrug antibodiesAntibodies (ADAs) to odronextamab over the study duration TiterMagnitude of ADAs to odronextamab over the study duration Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration Progression-freeFree survivalSurvival (PFS) as assessed by independent central review Event-freeFree survivalSurvival (EFS) as assessed by independent central review Overall survivalSurvival (OS) Duration ofOf responseResponse (DOR) assessed by independent central review Time toTo nextNext anti-lymphoma treatmentTreatment (TTNT) TiterMagnitude of ADAs [...] [...]
Primary endpoints4 entries, revised
Incidence of doseDose-limitingLimiting toxicitiesToxicities (DLTs) for odronextamab Incidence of treatmentTreatment-emergentEmergent adverseAdverse eventsEvents (TEAEs) of odronextamab
Study sites187 entries, revised
Hospital General Universitario de ToledoRobert-Bosch-Krankenhaus
Study title+6 characters
[...] Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Follicular Lymphoma
2025-07-18
Study Status, Contacts/Locations, References v28
Study sites187 entries, revised
Sakarya UniverstyUniversity Medical Faculty
2025-06-24
Study Status, Contacts/Locations, References v27
Study sites183→187
2025-06-13
Study Status, Contacts/Locations v26
Study sites174→183
2025-05-30
Study Status, Contacts/Locations v25
Study sites171→174
2025-05-15
Study Status, Contacts/Locations, IPDSharing v24
Study sites150→171
2025-04-22
Study Status, Contacts/Locations v23
Study sites149→150
2025-03-11
Study Status, Contacts/Locations v22
Study sites143→149
2025-02-18
Study Status, Contacts/Locations v21
Study sites140→143
2025-02-12
Study Status, Contacts/Locations v20
Study sites138→140
2025-02-03
Study Status, Contacts/Locations v19
Study sites137→138
2025-01-13
Study Status, Contacts/Locations v18
Study sites135→137
2024-12-18
Study Status, Contacts/Locations v17
Study sites133→135
2024-12-03
Study Status, Contacts/Locations v16
Study sites133 entries, revised
Hospital Universitary and PolitècnicPolitecnic La Fe
2024-11-26
Study Status, Contacts/Locations v15
Study sites129→133
2024-10-31
Study Status, Contacts/Locations v14
Study sites114→129
2024-10-02
Study Status, Contacts/Locations v13
Study sites103→114
2024-08-07
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v12
Primary completion date2029-04-03→2029-04-04
Completion date2029-04-03→2029-04-04
Eligibility criteria-2 characters
Key Inclusion Criteria: Diagnosis of clusterCluster of differentiationDifferentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / [...] sectional imaging documented by diagnostic imaging Computed tomographyTomography (CT) or Magnetic resonanceResonance imagingImaging (MRI) Eastern Cooperative Oncology Group (ECOG) performance [...] nction and hepatic function Key Exclusion Criteria: Central nervousNervous systemSystem (CNS) lymphoma or leptomeningeal lymphoma Histological evid [...] o a high-grade or diffuse large B-cell lymphoma Waldenström macroglobulinemiaMacroglobulinemia (WM, lymphoplasmacytic [...]
Secondary endpoints31 entries, revised
Incidence of anti-odronextamabdrug antibodies (ADAs) to odronextamab over the study duration Titer of ADAs to odronextamab over the study duration Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration Overall mean change from baseline in physical function [European Organization for Research an [...] 30 (EORTC-QLQ-C30)] Incidence of ADAs to odronextamab over timethe study duration Titer of ADAs to odronextamab over timethe study duration Incidence of NAbs to odronextamab over timethe study duration
Study sites103 entries, revised
Kaohsiung Medical University-Kaohsiung Medical University
Study titlerevised
A Trial to Learn if Odronextamab is Safe and Well-toleratedTolerated and How Well it Works Compared to Rituximab Combined With D [...]
2024-07-26
Study Status, Contacts/Locations v11
Study sites91→103
2024-06-27
Study Status, Contacts/Locations v10
Study sites71→91
2024-05-28
Study Status, Contacts/Locations v9
Study sites66→71
2024-04-30
Study Status, Contacts/Locations v8
Study sites51→66
2024-04-08
Study Status, Contacts/Locations v7
Study sites33→51
2024-03-25
Study Status, Contacts/Locations v6
Study sites24→33
2024-02-28
Study Status, Contacts/Locations v5
Study sites19→24
2024-02-05
Study Status, Contacts/Locations v4
Study sites10→19
2024-01-19
Study Status, Contacts/Locations v3
Study sites3→10
2023-12-14
Study Status v2
Start dateestimated 2023-11-14→confirmed 2023-12-12
2023-11-03
Study Status, Contacts/Locations v1
Primary completion date2029-03-14→2029-04-03
Completion date2029-03-14→2029-04-03
Start date2023-10-13→2023-11-14
Study sites1→3
2023-10-13
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Follicular Lymphoma
313 trials monitored
See 21 trials at risk
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.
Trial Details
NCT Number NCT06091254
Lead Sponsor Regeneron Pharmaceuticals
Conditions Follicular Lymphoma (FL)
Enrollment 822 participants
Start Date 2023-12-12
Primary Completion 2028-02-07 (estimated)
Study Completion 2029-11-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-11