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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.
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (93)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Tirol Kliniken GmbH
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InnsbruckAustriaRecruiting
Steiermaerkische Krankenanstalten Ges.m.b.H.
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LeobenAustriaRecruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaRecruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumRecruiting
Institut Jules Bordet
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BrusselsBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
CHR Verviers
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VerviersBelgiumRecruiting
Chu Ucl Namur
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YvoirBelgiumRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaRecruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyNot yet recruiting
Universitaet Des Saarlandes
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HomburgGermanyNot yet recruiting
Staedtisches Krankenhaus Kiel GmbH
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KielGermanyNot yet recruiting
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
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NeussGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Lucus Augusti
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LugoSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Complejo Hospitalario Universitario de Ourense
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OurenseSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitari Mutua Terrassa
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TerrassaSpainRecruiting
Hospital Universitario De Toledo Ute
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ToledoSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Centre Hospitalier Victor Dupouy
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Argenteuil CedexFranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
Centre Hospitalier De Cannes Simone Veil
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Cannes CedexFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Chorale Du Centre Hospitalier De Lens
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LensFranceRecruiting
Centre Hospitalier Du Puy
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Le Puy-En-VelayFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
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Mont-De-Marsan CedexFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Hôpital NOVO
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PontoiseFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Chu De Saint Etienne
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Saint-Etienne Cedex 2FranceRecruiting
Centre Hospitalier Saint Nazaire
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Saint Nazaire CedexFranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
European Institute Of Oncology S.r.l.
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MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Università degli Studi di Modena e Reggio Emilia
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ModenaItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda Ospedaliera Regionale San Carlo
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PotenzaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Azienda Sanitaria Locale Roma 2
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RomeItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyRecruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandRecruiting
Pratia S.A.
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
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WalbrzychPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.