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B-Cell Non-Hodgkin Lymphoma (B-NHL)Phase 3OLYMPIA-4NCT06230224

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

A Phase 3 study testing Odronextamab, Ifosfamide and Carboplatin in people with B-Cell Non-Hodgkin Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 81 sites in 14 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Non-Hodgkin Lymphoma (B-NHL)
What is being tested?
Odronextamab, Ifosfamide and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
81 sitesin 14 countries
Study dates
15 Feb 2024to 29 May 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

  • Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
  • Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
  • Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  • Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate hematologic and organ function.

Who cannot join

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
  • History of or current relevant CNS pathology, as described in the protocol
  • A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
  • 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
  • Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
  • Allergy/hypersensitivity to study drug, or excipients.
  • NOTE: Other protocol defined inclusion / exclusion criteria apply

Trial locations and contacts

81 sites in 14 countries.

81 sites in 14 countries

Brazil15 sites

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

  • Uopeccan Hospital do Cancer de Cascavel

    Cascavel, Paraná, 85806-300

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Amaral Carvalho Hospital

    Jaú, São Paulo, 17210-080

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Centro Gaucho Integrado

    Porto Alegre, Rio Grande do Sul, 90110-270

  • 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, 40285-000

  • Ensino e Terapia de Inovacao Clinica Amo (Etica)

    Salvador, Estado de Bahia, 41950-640

  • Hospital Sirio Libanes

    São Paulo, 01308-050

  • A Beneficencia Portuguesa de Sao Paulo, Oncology House

    São Paulo, 01321000

  • Instituto D'Or De Pesquisa e Ensino

    São Paulo, 04501-000

  • Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo

    São Paulo, 05403-000

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070

Other trials in Brazil

South Korea12 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

  • Asan Medical Center

    Seoul, 05505

  • Seoul St Marys Hospital

    Seoul, 06591

  • Yeouido St. Marys Hospital

    Seoul, 07345

  • St. Vincent Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247

  • Ulsan University Hospital

    Ulsan, 44033

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Turkey (Türkiye)11 sites

  • Gazi University

    Ankara, Central Anatolia, 06100

  • Sbu Dr.A.Y. Ankara Onkoloji Suam

    Ankara, 06100

  • VKV American Hopital

    Istanbul, 34365

  • Istanbul University

    Istanbul, 34418

  • Ege University

    Izmir, 35100

  • Ankara University Faculty of Medicine

    Mamak, Ankara, 06620

  • VM Medical Park Mersin Hospital

    Mezitli, Mersin, 33200

  • Sakarya University Medical Faculty

    Sakarya, 54290

  • Ondokuz Mayıs University

    Samsun, 55270

  • Tekirdag Namik Kemal University Hospital

    Tekirdağ, Suleymanpasa, 59100

  • Zonguldak Bulent Ecevit University

    Zonguldak, 67600

Other trials in Turkey (Türkiye)

Argentina9 sites

  • Hospital Aleman

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1118

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1280

  • Instituto Alexander Fleming

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426

  • Fundaleu - Fundacion Para Combatir La Leucemia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAN

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Hospital Privado Universitario de Cordoba

    Córdoba, X5016KEH

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900AUR

  • Hospital Alta Complejidad El Cruce

    San Juan Bautista, Buenos Aires, B1888AAE

Other trials in Argentina

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500-06

  • Show Chwan Memorial Hospital

    Changhua, 50008

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301

  • Taichung General Veterans Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan, Hunan Province, 33305

Other trials in Taiwan

Malaysia5 sites

  • Hospital Sultanah Aminah Jhor Bahru

    Johor Bahru, Johor, 80100

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88586

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Ampang

    Kuala Lumpur, Selangor, 68000

  • Subang Jaya Medical Center

    Subang Jaya, Selangor, 47500

Other trials in Malaysia

Spain4 sites

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120

  • Clinica Universidad de Navarra- Pamplona

    Pamplona, 31008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Thailand4 sites

  • Chulalongkorn University

    Bangkok, 10330

  • Sriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

Hungary3 sites

  • Semmelweis University

    Budapest, 1088

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032

  • University of Pecs

    Pécs, Baranya, 7624

Other trials in Hungary

Australia2 sites

  • Olivia Newton John Cancer Wellness & Research Centre

    Heidelberg, Victoria, 3084

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Chile2 sites

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan, 7500921

  • Clinica Alemana de Santiago

    Santiago, Santiago Metropolitan, 7650620

Other trials in Chile

Colombia2 sites

  • Clinica Imbanaco

    Cali, Valle del Cauca Department, 760042

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia, 050034

Other trials in Colombia

Romania2 sites

  • Coltea Clinical Hospital

    Bucharest, Bucharest, 030141

  • Ion Chiricuta Oncology Institute

    Cluj-Napoca, Cluj, 400015

Other trials in Romania

Singapore1 site

  • National University Hospital Singapore

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug versus Standard of Care (SOC)
  • 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)
  • Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities
Being tested
Odronextamab, Ifosfamide, Carboplatin, Etoposide, Rituximab
Keywords
Non-Hodgkin lymphomas (NHLs), Aggressive NHL, B-Cell Non-Hodgkin Lymphoma (B-NHL), Odronextamab, Anti-CD20 × anti-CD3 bispecific antibody, Relapsed/Refractory NHL
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • OdronextamabDrug

    Also called R1979

    Administered by intravenous (IV) infusion

  • IfosfamideDrug

    Also called Ifex

    Administered by IV infusion, as part of the ICE ± R salvage therapy

  • CarboplatinDrug

    Also called Paraplatin

    Administered by IV infusion, as part of the ICE ± R salvage therapy

  • EtoposideDrug

    Also called Etopophos

    Administered by IV infusion, as part of the ICE ± R salvage therapy

  • RituximabDrug

    Also called Rituxan

    Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

  • DexamethasoneDrug

    Also called Decadron

    Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

  • CisplatinDrug

    Also called Platinol

    Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

  • CytarabineDrug

    Also called Cytosar-U

    Administered by IV infusion, as part of the DHAP ± R salvage therapy.

  • GemcitabineDrug

    Also called Gemzar

    Administered by IV infusion, as part of the GDP ± R salvage therapy.

Study groups in NCT06230224
Study groupRoleWhat they receive
OdronextamabExperimentalParticipants will receive odronextamab monotherapy.
Receives: Drug: Odronextamab
Standard Of CareActive comparatorParticipants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab [ICE ± R], or dexamethasone, cisplatin, cytarabine ± rituximab [DHAP ± R], or gemcitabine, dexamethasone, cisplatin ± rituximab [GDP ± R]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR).
Receives: Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Rituximab; Drug: Dexamethasone; Drug: Cisplatin; Drug: Cytarabine; Drug: Gemcitabine

What is being measured

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

  1. Event-free survival (EFS) as assessed by independent central review (ICR)

    Measured: Assessed up to 3 years

Secondary outcomes (22)

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

    Measured: Assessed up to 3 years

  2. Best overall response (BOR) as assessed by ICR

    Measured: Assessed up to 6 months

  3. Overall survival (OS)

    Measured: Assessed up to 3 years

  4. Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)

    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: Assessed up to 3 years

  5. EFS as assessed by local investigator

    Measured: Assessed up to 3 years

  6. PFS as assessed by local investigator

    Measured: Assessed up to 3 years

  7. BOR as assessed by local investigator

    Measured: Assessed up to 6 months

  8. Complete response (CR) as assessed by ICR

    Measured: Assessed up to 6 months

  9. CR as assessed by local investigator

    Measured: Assessed up to 6 months

  10. Duration of response (DOR) assessed by ICR

    Measured: Assessed up to 3 years

  11. DOR assessed by local investigator

    Measured: Assessed up to 3 years

  12. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Assessed up to 1 year

  13. Severity of TEAEs

    Measured: Assessed up to 1 year

  14. Odronextamab concentrations in serum

    Measured: Assessed up to 6 months

  15. Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration

    Measured: Assessed up to 6 months

  16. Titers of ADAs to odronextamab over the study duration

    Measured: Assessed up to 6 months

  17. Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration

    Measured: Assessed up to 6 months

  18. Measurable residual disease (MRD) status

    Measured: Assessed up to 6 months

  19. Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30

    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: Assessed up to 3 years

  20. Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)

    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: Assessed up to 3 years

  21. Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)

    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: Assessed up to 3 years

  22. Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire

    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: Assessed up to 3 years

Timeline

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

  1. First posted30 Jan 2024
  2. Study start15 Feb 2024
  3. Primary completion29 May 2028 (estimated)
  4. Study completion29 May 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
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230224
Sponsor's protocol ID
R1979-HM-2299
Other IDs
2022-502783-21-00
Acronym
OLYMPIA-4
Status last verified
May 2026
First submitted
29 Dec 2023
Last updated
11 May 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, Ifosfamide and Carboplatin in people with B-Cell Non-Hodgkin Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 81 sites in 14 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 6 inclusion and 7 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Brazil, South Korea, Turkey (Türkiye), Argentina, Taiwan and 9 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?

Event-free survival (EFS) as assessed by independent central review (ICR) (time frame: Assessed up to 3 years). 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 NCT06230224.

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 11 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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