NCT06097364RecruitingPhase 3
A Trial to Learn if Odronextamab Combined with Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined with Chemotherapy for Adult Participants with Follicular Lymphoma
A Phase 3, Open-Label, Randomized Study To Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Combined with Chemotherapy versus Rituximab Combined with Chemotherapy in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-2)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Jun 2026
Brief summary (registry, in English)
Part 1 Assess the safety, tolerability, and dose limiting toxicities (DLTs) of odronextamab in combination with chemotherapy in participants with previously untreated follicular lymphoma (FL) and participants with relapsed or refractory (R/R) FL (Part 1A only), and to determine an optimal dosing regimen of odronextamab (Part 1B) in previously untreated participants with FL to combine with CHOP/CVP in Part 2. Part 2 To compare the efficacy of odronextamab in combination with chemotherapy versus rituximab in combination with chemotherapy in participants with previously untreated FL as measured by complete response rate at 30 months (CR30) per independent central review.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 28 Jun 2023
- Start date
- 1 Feb 2024
- Lead sponsor
- Regeneron Pharmaceuticals Inc.
- Diseases
- Follicular lymphoma
- EU CT number
- 2022-502113-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 220
- 93 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent major surgery and history or organ transplantation
Other illness
- A malignancy other than NHL unless the participant is adequately and definitively treated and 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
Other
- Participants with central nervous system lymphoma or leptomeningeal lymphoma
- Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- NOTE: Other protocol defined exclusion criteria apply
Who the study is looking for
- Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow and hepatic function
- NOTE: Other protocol defined inclusion criteria apply
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (93)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Tirol Kliniken GmbH Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Steiermaerkische Krankenanstalten Ges.m.b.H. Coordinator of this site? Confirm its status | Leoben | Austria | Recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Recruiting |
| CHR Verviers Coordinator of this site? Confirm its status | Verviers | Belgium | Recruiting |
| Chu Ucl Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| Fakultní Nemocnice Královské Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Universitaet Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Not yet recruiting |
| Staedtisches Krankenhaus Kiel GmbH Coordinator of this site? Confirm its status | Kiel | Germany | Not yet recruiting |
| MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Complejo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Hospital Universitario De Toledo Ute Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| Centre Hospitalier De Cannes Simone Veil Coordinator of this site? Confirm its status | Cannes Cedex | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Chorale Du Centre Hospitalier De Lens Coordinator of this site? Confirm its status | Lens | France | Recruiting |
| Centre Hospitalier Du Puy Coordinator of this site? Confirm its status | Le Puy-En-Velay | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Coordinator of this site? Confirm its status | Mont-De-Marsan Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Chu De Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne Cedex 2 | France | Recruiting |
| Centre Hospitalier Saint Nazaire Coordinator of this site? Confirm its status | Saint Nazaire Cedex | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Università degli Studi di Modena e Reggio Emilia Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliera Regionale San Carlo Coordinator of this site? Confirm its status | Potenza | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Sanitaria Locale Roma 2 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Coordinator of this site? Confirm its status | Walbrzych | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.