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A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Study acronym: OLYMPIA-3
StatusRecruiting
PhasePhase 3
Started2023-12-13
View on ClinicalTrials.gov ↗

Amendment history

2026-09-11
Study Status, Contacts/Locations v34
Trial sites expanded: 185 → 190 locations
Trial sites expanded: 178 → 185 locations
2026-08-19
Study Status, Contacts/Locations v33
Trial sites expanded: 172 → 178 locations
2026-08-05
Study Status, Contacts/Locations v32
Trial sites expanded: 168 → 172 locations
2026-07-21
Study Status, Contacts/Locations v31
Study sites166→168
2026-07-07
Study Status, Contacts/Locations v30
Trial sites expanded: 155 → 166 locations
2026-06-12
Study Status, Contacts/Locations v29
Study sitesdetails revised at 1 of 155 sites
2026-05-14
Study Status, Contacts/Locations v28
Trial status changed: Active, Not Recruiting → Recruiting
Trial sites expanded: 149 → 155 locations
Completion date2029-09-02→2029-09-12
2026-02-03
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v27
Completion date2029-04-30→2029-09-02
Eligibility criteria-12 characters
KEYKey Inclusion Criteria: Previously untreated participants for lymphoma with documented clusterCluster of differentiationDifferentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed [...] to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only; Adequate hematologic and organ function, as defined in the protocol. KEYKey Exclusion Criteria: Primary centralCentral nervousNervous systemSystem (CNS) lymphoma or known involvement by non-primary CNS NHL [...] ystemic anti-lymphoma therapy, except for participants with relapsedRelapsed/refractoryRefractory (R/R) DLBCL and participants with DL [...] [...]
Secondary endpoints25 to 23 entries
Event-freeFree survivalSurvival (EFS) assessed by ICR Complete responseResponse (CR) assessed by ICR Overall survivalSurvival (OS) Best Overall responseResponse (BOR) as assessed by local investigators Duration of responseResponse (DOR) as assessed by local investigators IncidenceOccurrence of antiAnti-drugDrug antibodiesAntibodies (ADA) to odronextamab over the study duration TiterMagnitude of ADA to odronextamab over the study duration Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration MeasurableMinimal Residual Disease (MRD) status Duration of MRD-negativity
Primary endpoints4 entries, revised
Incidence of doseDose limitingLimiting toxicitiesToxicities (DLTs) Incidence of treatmentTreatment emergentEmergent adverseAdverse eventsEvents (TEAEs) Progression freeFree survivalSurvival (PFS), assessed by independentIndependent centralCentral reviewReview (ICR)
Study sites149 entries, revised
CHUCentro Oncologia de Precision Universidad Mayor Centre Hospitalier Universitaire De Poitiers BeaumontAidport Wielospecjalistyczne Hospital PratiaCentrum PoznanOnkologii Medicali Center Szpital Uniwersytecki Nr2 BydgoszczTraumatologii Hospital Universitario Central Dede Asturias Hospital Universitario HM Sanchinarro, Servicio Universitat de Hematologia Valencia - Hospital GeneralUniversitari Universitarioi Politecnic La Fe de ToledoValencia (Hospital La Fe Bulevar Sur) Chang Gung Memorial Hospital - Linkou Branch Sakarya UniverstyUniversity Medical Faculty
Study title+6 characters
[...] Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
2025-05-12
Study Status, Contacts/Locations, IPDSharing v26
Study sites148→149
2025-04-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2028-09-18→2028-03-30
Completion date2028-09-18→2029-04-30
Study sitesdetails revised at 148 of 148 sites
2025-04-14
Study Status, Contacts/Locations v24
Study sites147→148
2025-03-20
Study Status, Contacts/Locations v23
Study sites146→147
2025-01-27
Study Status, Contacts/Locations v22
Study sites145→146
2025-01-16
Study Status, Contacts/Locations v21
Study sites142→145
2024-12-10
Study Status, Contacts/Locations v20
Study sites142 entries, revised
Hopital Saint Vincent-de-Paul St. Vincent Hospital, - The Catholic University of Korea Yeouido St. Marys Hospital
2024-11-22
Study Status, Contacts/Locations v19
Study sites141→142
2024-11-07
Study Status, Contacts/Locations v18
Study sites139→141
2024-10-28
Study Status, Outcome Measures, Eligibility, Contacts/Locations v17
Study sites131→139
Eligibility criteria+118 characters
[...] as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) Measurable disease with at least one nodal l [...]
Secondary endpoints25 entries, revised
Incidence of anti-drug antibodies (ADA) to odronextamab whenover administeredthe withstudy CHOPduration Titer of ADA to odronextamab whenover administeredthe withstudy CHOPduration Incidence of neutralizing antibodies (NAb) to odronextamab whenover administeredthe withstudy CHOPduration
2024-09-30
Study Status, Contacts/Locations v16
Study sites124→131
2024-09-06
Study Status, Contacts/Locations v15
Study sites118→124
2024-08-19
Study Status, Contacts/Locations v14
Study sites114→118
2024-07-24
Study Status, Contacts/Locations v13
Study sites104→114
2024-07-08
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Study sites95→104
Eligibility criteria+211 characters
[...] y Grade ≥3 Treatment with any systemic anti-lymphoma therapy, except for participants with relapsed/refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent follicular lymphoma after treatment with systemic anti-lymphoma therapy. Any other therapy or investigational therapytreatment within 28 days or 5 half-lives of the drug, whichever is sh [...]
Secondary endpoints25 entries, revised
Change in physical functioning as measured by EORTC QLQ C30 Change from baseline of patient reported outcomes, as measured by European Organization for Research and Treat [...] Quality of Life Core Questionnaire (EORTC QLQ-C) 30 Change fromin baselinepatient ofreported outcomes, as measured by EORTC QLQ-C30 Change in patient reported outcomes, as measured by Functional Assess [...] nt of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Change from baseline ofin patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS) Change from baseline ofin patient reported outcomes, as measur [...] [...]
2024-06-18
Study Status, Contacts/Locations v11
Study sites86→95
2024-05-28
Study Status, Contacts/Locations v10
Study sites76→86
2024-04-29
Study Status, Contacts/Locations v9
Study sites64→76
2024-04-05
Study Status, Contacts/Locations v8
Study sites46→64
2024-03-15
Study Status, Contacts/Locations v7
Study sites31→46
2024-02-29
Study Status, Contacts/Locations v6
Study sites24→31
2024-02-07
Study Status, Contacts/Locations v5
Study sites16→24
2024-01-23
Study Status, Contacts/Locations v4
Study sites8→16
2024-01-04
Study Status, Contacts/Locations v3
Start dateestimated 2023-12-11→confirmed 2023-12-13
Study sites3→8
2023-11-30
Study Status v2
Primary completion date2028-08-29→2028-09-18
Completion date2028-08-29→2028-09-18
Start date2023-11-20→2023-12-11
2023-11-02
Study Status, Contacts/Locations v1
Primary completion date2028-08-11→2028-08-29
Completion date2028-08-11→2028-08-29
Start date2023-10-18→2023-11-20
Study sites1→3
2023-10-13
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
DLBCL
648 trials monitored
See 32 trials at risk
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy * 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) * The impact from the study drug on quality of life and ability to complete routine daily activities
Trial Details
NCT Number NCT06091865
Lead Sponsor Regeneron Pharmaceuticals
Conditions Diffuse Large B-cell Lymphoma (DLBCL)
Enrollment 904 participants
Start Date 2023-12-13
Primary Completion 2028-03-30 (estimated)
Study Completion 2029-09-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25