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AzTrials

Follicular Lymphoma (FL)Phase 3OLYMPIA-2NCT06097364

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 study testing Odronextamab, Rituximab and Cyclophosphamide in people with Follicular Lymphoma (FL), run by Regeneron Pharmaceuticals at 145 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma (FL)
What is being tested?
Odronextamab, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
733 participants
Where
145 sitesin 17 countries
Study dates
14 Nov 2023to 29 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
  • For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
  • For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
  • For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
  • 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.

Who cannot join

  • 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
  • Recent major surgery and history or organ transplantation
  • 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.
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

145 sites in 17 countries.

145 sites in 17 countries

Brazil22 sites

  • Fundacao Pio XII Hospital de Amor

    Barretos, São Paulo, 14784-400

  • Instituto Mario Pena de Ensino Pesquisa e Inovacao

    Belo Horizonte, Minas Gerais, 30380-472

  • Instituto Tacchini de Pesquisa em Saude

    Bento Gonçalves, Rio Grande do Sul, 95700-084

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

  • Instituto DOr de Pesquisa e Ensino Df Star

    Brasília, Federal District, 70390-140

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Amaral Carvalho Hospital

    Jaú, São Paulo, 17210-080

  • Centro de Hematologia e Oncologia

    Joinville, Santa Catarina, 89201-260

  • Animi Unidade de Tratamento Oncologico Ltda

    Lages, Santa Catarina, 88501-001

  • Liga Norte Riograndense Contra o Cancer

    Natal, Rio Grande do Norte, 59062-000

  • Instituto do Cancer em Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, São Paulo, 14048-900

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva

    Rio de Janeiro, 20231050

  • Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41253-900

  • Ensino e Terapia de Inovacao Clinica Amo (Etica)

    Salvador, Estado de Bahia, 41950-640

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903

  • AC Camargo Cancer Center

    São Paulo, 01509-010

  • Clinical Hospital of Medicine School at Sao Paulo University

    São Paulo, 05403-000

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070

  • Centro Oncologico do Triangulo (COT) - Uberlandia

    Uberlândia, Minas Gerais, 38408-008

Other trials in Brazil

Spain21 sites

  • Hospital General Universitario Doctor Balmis Alicante

    Alicante, Valencia, 03010

  • Cruces University Hospital (Hospital Universitario Cruces)

    Barakaldo, Bizkaia, 48903

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Complexo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

  • Clinica Universidad de Navarra- Pamplona

    Pamplona, 31008

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona, 08221

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy15 sites

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forli-Cesena, 47014

  • ASST Grande Ospedale Metropolitano Niguarda - Main Address

    Milan, 20162

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Istituto Europeo di Oncologia

    Milan, 20141

  • A.O.U. di Modena

    Modena, 41124

  • Federico II University

    Naples, 80131

  • Azienda Ospedaliera Universitario Policlinico Palermo

    Palermo, Sicily, 90127

  • Azienda Ospedaliera di Perugia

    Perugia, 06132

  • University of Pisa, Section of Hematology

    Pisa, 56126

  • Azienda Ospedaliera Regionale San Carlo

    Potenza, 85100

  • UO Ematologia Ravenna

    Ravenna, 48121

  • Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Azienda Osperdaliero-Universitaria Policlinico Umberto 1

    Rome, 00161

  • Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin

    Turin, Piedmont, 10137

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100

Other trials in Italy

France14 sites

  • Hopital Victor Dupouy Argenteuil

    Argenteuil, Île-de-France Region, 95100

  • Cannes Hospital (Centre Hospitalier Cannes Simone Veil)

    Cannes, Alpes Maritimes, 06400

  • The Novo Hospital North West Val Deoise

    Cergy-Pontoise, Pontoise, 95300

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, 43012

  • Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)

    Lens, 62300

  • Centre Hospitalier de Mont-de-Marsan

    Mont-de-Marsan, New Aquitaine, 40024

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093

  • Institut de Cancerologie du Gard

    Nîmes, Gard, 30029

  • Hopital Saint Louis

    Paris, 75010

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque

    Pessac, 33600

  • CHU de Saint-Etienne

    Saint-Etienne, 42055

  • Centre Hospitalier de Saint Nazaire

    Saint-Nazaire, 44600

  • CHRU de Tours

    Tours, Centre-Val de Loire, 37044

Other trials in France

Turkey (Türkiye)12 sites

  • Gazi University

    Ankara, Central Anatolia, 06100

  • Liv Hospital Ankara

    Ankara, 06100

  • VKV American Hopital

    Istanbul, 34365

  • Istanbul University

    Istanbul, 34418

  • Erci̇yes Uni̇versi̇ty

    Kayseri, 38039

  • Ankara University Faculty of Medicine

    Mamak, Ankara, 06620

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin, 33200

  • Sakarya University

    Sakarya, Serdivan, 54050

  • Ondokuz Mayıs University

    Samsun, 55270

  • Tekirdag Namik Kemal University Hospital

    Tekirdağ, Suleymanpasa, 59100

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Yenimahalle, Ankara, 06200

  • Zonguldak Bulent Ecevit University

    Zonguldak, 67100

Other trials in Turkey (Türkiye)

United States9 sites

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Center for Oncology and Blood Disorders

    Houston, Texas, 77030

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Investigative Clinical Research of Indiana

    Noblesville, Indiana, 46062

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Boca Raton Clinical Research (BRCR) Global

    Plantation, Florida, 33322

  • Prohealth Care Inc

    Waukesha, Wisconsin, 53188

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Poland9 sites

  • Szpital Uniwersytecki Nr2 Bydgoszcz

    Bydgoszcz, 85-168

  • Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center

    Gdansk, 80-952

  • Pratia Onkologia Katowice

    Katowice, 40-519

  • Matopolskie Centrum Medyczne S.C.

    Krakow, Lesser Poland Voivodeship, 30-510

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

    Lodz, 93-513

  • Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Aidport

    Skorzewo, Wielkopolska, 60185

  • Szpital Szpecjalistyczny w Walbrzychu

    Wałbrzych, 58-300

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

    Warsaw, 02781

Other trials in Poland

Austria7 sites

  • Medical University of Graz

    Graz, Styria, 8036

  • Innsbruck Medical University

    Innsbruck, Tyrol, 6020

  • Landeskrankenhaus Hochsteiermark

    Leoben, Styria, 8700

  • Kepler University Hospital

    Linz, Upper Austria, 4020

  • Karl Landsteiner University Hospital St. Poelten

    Sankt Pölten, Lower Austria, 3100

  • Universitatsklinik fur Kinder und Jungendheilkunde

    Vienna, 1090

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Israel7 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 91200

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Assuta Medical Centers

    Tel Aviv, 6971028

Other trials in Israel

Belgium6 sites

  • Algemeen Ziekenhuis St Jan Brugge Oostende Av

    Bruges, West-Vlaanderen, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • Verenigde Ziekenhuizen van Waas en Durme

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Taiwan6 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Taipei Medical University Multipal Wan Fang University

    Taipei, 11696

Other trials in Taiwan

Chile4 sites

  • Hospital Clinico Universidad de Los Andes

    Santiago, Las Condes, 7620157

  • Pontificia Universidad Catolica de Chile

    Santiago, Santiago Metropolitan, 7550000

  • Centro Oncologia de Precision Universidad Mayor

    Santiago, Santiago Metropolitan, 7560907

  • Inmunocel

    Santiago, Santiago Metropolitan, 7580206

Other trials in Chile

United Kingdom4 sites

  • NHS Grampian: Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2SY

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

  • The Hillingdon Hospitals NHS Foundation Trust

    Uxbridge, London, UB8 3NN

Other trials in United Kingdom

Australia3 sites

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Czechia2 sites

  • University Hospital Brno

    Brno, South Moravian, 62500

  • University Hospital Hradec Kralove

    Hradec Králové, North Central Czech Republic, 50005

Other trials in Czechia

Germany2 sites

  • Stadtisches Krankenhaus Kiel

    Kiel, 24116

  • MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH

    Neuss, 41462

Other trials in Germany

Thailand2 sites

  • Chulalongkorn University

    Bangkok, Krung Thep Maha Nakhon [Bangko], 10330

  • Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study.

This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled).

Read more

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 to be used in Part 2 of the study.

The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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)
  • The impact from the study drug on quality-of-life and ability to complete routine daily activities
Being tested
Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Keywords
Non-Hodgkin lymphomas (NHL), Relapsed or Refractory (R/R) FL, B-cells NHL (B-NHL), Untreated FL, Odronextamab
Medical subject headings
Lymphoma, Follicular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdronextamabDrug

    Also called REGN1979

    Administered by intravenous (IV) infusion

  • RituximabDrug

    Also called Rituxan

    Administered by IV infusion, or subcutaneous (SC)

  • CyclophosphamideDrug

    Also called Cytoxan

    Administered by IV infusion

  • DoxorubicinDrug

    Also called Adriamycin

    Administered by IV infusion

  • VincristineDrug

    Also called Oncovin

    Administered by IV infusion

  • Prednisone/PrenisoloneDrug

    Also called Deltasone/Omnipred

    Administered orally (PO)

Study groups in NCT06097364
Study groupRoleWhat they receive
Odronextamab + ChemotherapyExperimentalPart 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
Receives: Drug: Odronextamab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone/Prenisolone
Rituximab + ChemotherapyActive comparatorIn Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
Receives: Drug: Odronextamab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prenisolone
Odronextamab + Chemotherapy + MaintenanceExperimentalIn Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy [CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)], followed by odronextamab monotherapy maintenance.
Receives: Drug: Odronextamab; Drug: Vincristine
Odronextamab + Chemotherapy + No maintenanceExperimentalIn Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
Receives: Drug: Odronextamab; Drug: Vincristine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy

    Part 1, DLT period

    Measured: Up to 35 days

  2. Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy

    Part 1, Treatment period

    Measured: Up to 2 years

  3. Severity of TEAEs of odronextamab in combination with chemotherapy

    Part 1, Treatment period

    Measured: Up to 2 years

  4. Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)

    Part 2

    Measured: Up to 30 months

Secondary outcomes (30)

  1. Odronextamab concentrations in serum when administered with chemotherapy

    Part 1, Maintenance period and Part 2, Induction period

    Measured: Up to 30 months

  2. Odronextamab concentrations in serum when administered as monotherapy

    Part 1 and Part 2, Maintenance period

    Measured: Up to 30 months

  3. Incidence of anti-odronextamab antibodies (ADAs)

    Part 1 and Part 2

    Measured: Up to 30 months

  4. Titers of ADAs to odronextamab

    Part 1 and Part 2

    Measured: Up to 30 months

  5. Incidence of neutralizing antibodies (NAb) to odronextamab

    Part 1 and Part 2

    Measured: Up to 30 months

  6. Best overall response (BOR) as assessed by the investigator

    Part 1, end of Induction period and end of Maintenance period

    Measured: Up to 30 months

  7. Progression free survival (PFS) as assessed by ICR

    Part 2

    Measured: Up to 5 years

  8. CR30 as assessed by local investigator

    Part 2

    Measured: Up to 30 months

  9. Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  10. PFS as assessed by local investigator

    Part 2

    Measured: Up to 5 years

  11. Event-free survival (EFS) as assessed by ICR

    Part 2

    Measured: Up to 5 years

  12. EFS as assessed by local investigator

    Part 2

    Measured: Up to 5 years

  13. Overall Survival (OS)

    Part 2

    Measured: Up to 5 years

  14. BOR as assessed by local investigator

    Part 2

    Measured: Up to 30 months

  15. BOR as assessed by ICR

    Part 2

    Measured: Up to 30 months

  16. Duration of response (DOR) assessed by ICR

    Part 2

    Measured: Up to 5 years

  17. DOR as assessed by local investigator

    Part 2

    Measured: Up to 5 years

  18. Time to next anti-lymphoma treatment (TTNT)

    Part 2

    Measured: Up to 5 years

  19. Incidence of TEAEs

    Part 2

    Measured: Up to 2 years

  20. Severity of TEAEs

    Part 2

    Measured: Up to 2 years

  21. Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  22. Change in cancer disease as measured by EORTC-QLQ-C30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  23. Change in treatment related symptoms as measured by EORTC-QLQ-C30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  24. Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)

    Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

    Measured: Up to 5 years

  25. Change in treatment-related symptoms as measured by the FACT-LymS

    Part 2 The FACT-LymS includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

    Measured: Up to 5 years

  26. Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

    Measured: Up to 5 years

  27. Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)

    Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

    Measured: Up to 5 years

  28. Change in Patient Global Impression of Severity (PGIS)

    Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).

    Measured: Up to 5 years

  29. Change in Patient Global Impression of Change (PGIC)

    Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.

    Measured: Up to 5 years

  30. Change in score of the FACT-G GP5 item in the patient population

    Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start14 Nov 2023
  3. Primary completion29 Jul 2029 (estimated)
  4. Study completion29 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
733 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097364
Sponsor's protocol ID
R1979-ONC-2075
Other IDs
2022-502113-28-00
Acronym
OLYMPIA-2
Status last verified
Sep 2025
First submitted
18 Oct 2023
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Odronextamab, Rituximab and Cyclophosphamide in people with Follicular Lymphoma (FL), run by Regeneron Pharmaceuticals at 145 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in Brazil, Spain, Italy, France, Turkey (Türkiye) and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy (time frame: Up to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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