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

NCT06230224 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R1979-HM-22992022-502783-21-00
• Study Type: interventional
• Target: 216
• Locations: 16 countries
• Sites: 101

Brief 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'). 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

Conditions

B-Cell Non-Hodgkin Lymphoma (B-NHL)

Keywords

Non-Hodgkin lymphomas (NHLs); Aggressive NHL; B-Cell Non-Hodgkin Lymphoma (B-NHL); Odronextamab; Anti-CD20 × anti-CD3 bispecific antibody; Relapsed/Refractory NHL

Outcome Measures

Primary Outcomes (1)

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

  Assessed up to 3 years

Secondary Outcomes (22)

• Progression free survival (PFS) as assessed by ICR

  Assessed up to 3 years

• Best overall response (BOR) as assessed by ICR

  Assessed up to 6 months

• Overall survival (OS)

  Assessed up to 3 years

• 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)

  Assessed up to 3 years

• EFS as assessed by local investigator

  Assessed up to 3 years

Study Arms (2)

Odronextamab

EXPERIMENTAL

Participants will receive odronextamab monotherapy.

Drug: Odronextamab

Standard Of Care

ACTIVE COMPARATOR

Participants 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).

Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Rituximab; Drug: Dexamethasone; Drug: Cisplatin; Drug: Cytarabine; Drug: Gemcitabine

Interventions

Odronextamab DRUG

Administered by intravenous (IV) infusion

Also known as: R1979

Odronextamab

Ifosfamide DRUG

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

Also known as: Ifex

Standard Of Care

Carboplatin DRUG

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

Also known as: Paraplatin

Standard Of Care

Etoposide DRUG

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

Also known as: Etopophos

Standard Of Care

Rituximab DRUG

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

Also known as: Rituxan

Standard Of Care

Dexamethasone DRUG

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

Also known as: Decadron

Standard Of Care

Cisplatin DRUG

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

Also known as: Platinol

Standard Of Care

Cytarabine DRUG

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

Also known as: Cytosar-U

Standard Of Care

Gemcitabine DRUG

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

Also known as: Gemzar

Standard Of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (101)

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1118, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1280, Argentina

RECRUITING

Instituto Alexander Fleming

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426, Argentina

RECRUITING

Fundaleu - Fundacion Para Combatir La Leucemia

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1114AAN, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AUR, Argentina

RECRUITING

Hospital Alta Complejidad El Cruce

San Juan Bautista, Buenos Aires, B1888AAE, Argentina

RECRUITING

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

RECRUITING

Hospital Privado Universitario de Cordoba

Córdoba, X5016KEH, Argentina

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

WITHDRAWN

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

WITHDRAWN

Olivia Newton John Cancer Wellness & Research Centre

Heidelberg, Victoria, 3084, Australia

RECRUITING

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

RECRUITING

Hospital Sao Rafael

Salvador, Estado de Bahia, 40285-000, Brazil

RECRUITING

Ensino e Terapia de Inovacao Clinica Amo (Etica)

Salvador, Estado de Bahia, 41950-640, Brazil

RECRUITING

Hospital Sirio Libanes Brasilia

Brasília, Federal District, 70200-730, Brazil

RECRUITING

Uopeccan Hospital do Cancer de Cascavel

Cascavel, Paraná, 85806-300, Brazil

RECRUITING

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Centro Gaucho Integrado

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

RECRUITING

Amaral Carvalho Hospital

Jaú, São Paulo, 17210-080, Brazil

RECRUITING

Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio de Janeiro, 20231050, Brazil

RECRUITING

Hospital Sirio Libanes

São Paulo, 01308-050, Brazil

RECRUITING

A Beneficencia Portuguesa de Sao Paulo, Oncology House

São Paulo, 01321000, Brazil

RECRUITING

Instituto D'Or De Pesquisa e Ensino

São Paulo, 04501-000, Brazil

RECRUITING

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

São Paulo, 05403-000, Brazil

RECRUITING

Casa de Saude Santa Marcelina

São Paulo, 08270-070, Brazil

RECRUITING

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, 7500921, Chile

RECRUITING

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7650620, Chile

RECRUITING

Hospital Pablo Tobon Uribe

Medellín, Antioquia, 050034, Colombia

RECRUITING

Clinica Imbanaco

Cali, Valle del Cauca Department, 760042, Colombia

RECRUITING

University of Pecs

Pécs, Baranya, 7624, Hungary

RECRUITING

Debreceni Egyetem

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Semmelweis University

Budapest, 1088, Hungary

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Forli-Cesena, 47014, Italy

WITHDRAWN

Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute

Aviano, Pordenone, 33081, Italy

WITHDRAWN

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

WITHDRAWN

AOU Maggiore della Carita

Novara, 28100, Italy

WITHDRAWN

Ospedale di Circolo e Fondazione Macchi Varese

Varese, 21100, Italy

WITHDRAWN

Hospital Sultanah Aminah Jhor Bahru

Johor Bahru, Johor, 80100, Malaysia

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88586, Malaysia

RECRUITING

Hospital Ampang

Kuala Lumpur, Selangor, 68000, Malaysia

RECRUITING

Subang Jaya Medical Center

Subang Jaya, Selangor, 47500, Malaysia

RECRUITING

Erasmus University Medical Center

Rotterdam, 1079NG, Netherlands

WITHDRAWN

Coltea Clinical Hospital

Bucharest, București, 030141, Romania

RECRUITING

Ion Chiricuta Oncology Institute

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

National University Hospital Singapore

Singapore, 119074, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

WITHDRAWN

National Cancer Center

Gyeonggi-do, Gyeonggi-do, 10408, South Korea

RECRUITING

St. Vincent Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Namdong-Gu, 21565, South Korea

RECRUITING

Dong-A University Hospital

Busan, 49201, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Yeyungnam University Medical Center

Daegu, 42415, South Korea

WITHDRAWN

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Seoul St Marys Hospital

Seoul, 06591, South Korea

RECRUITING

Yeouido St. Marys Hospital

Seoul, 07345, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, 44033, South Korea

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

WITHDRAWN

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

COMPLETED

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

WITHDRAWN

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

WITHDRAWN

Hospital Virgen De Las Nieves De Granada

Granada, 18014, Spain

WITHDRAWN

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

WITHDRAWN

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

WITHDRAWN

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Fundacion Jimenez Diaz University Hospital

Madrid, 28040, Spain

WITHDRAWN

Clinica Universidad de Navarra- Pamplona

Pamplona, 31008, Spain

RECRUITING

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

COMPLETED

University Hospital Doctor Peset

Valencia, 46017, Spain

WITHDRAWN

Chang Gung Medical Foundation

Chiayi City, Chianan Plain, 613, Taiwan

WITHDRAWN

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan District, Hunan Province, 33305, Taiwan

RECRUITING

Changhua Christian Hospital

Changhua, 500-06, Taiwan

RECRUITING

Show Chwan Memorial Hospital

Changhua, 50008, Taiwan

RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, 83301, Taiwan

RECRUITING

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

WITHDRAWN

Taichung General Veterans Hospital

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 11490, Taiwan

RECRUITING

Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Sriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Khon Kaen University

Khon Kaen, 40002, Thailand

RECRUITING

Ankara University Faculty of Medicine

Mamak, Ankara, 06620, Turkey (Türkiye)

RECRUITING

Gazi University

Ankara, Central Anatolia, 06100, Turkey (Türkiye)

RECRUITING

VM Medical Park Mersin Hospital

Mezitli, Mersin, 33200, Turkey (Türkiye)

RECRUITING

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)

RECRUITING

Sbu Dr.A.Y. Ankara Onkoloji Suam

Ankara, 06100, Turkey (Türkiye)

RECRUITING

VKV American Hopital

Istanbul, 34365, Turkey (Türkiye)

RECRUITING

Istanbul University

Istanbul, 34418, Turkey (Türkiye)

RECRUITING

Ege University

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Sakarya University Medical Faculty

Sakarya, 54290, Turkey (Türkiye)

RECRUITING

Ondokuz Mayıs University

Samsun, 55270, Turkey (Türkiye)

RECRUITING

Zonguldak Bulent Ecevit University

Zonguldak, 67600, Turkey (Türkiye)

RECRUITING

Related Links

• OLYMPIA

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Interventions

Ifosfamide; Carboplatin; Etoposide; etoposide phosphate; Rituximab; Dexamethasone; Calcium Dobesilate; Cisplatin; Cytarabine; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 30, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

CL (2); HU (3); AR (9); AU (4); BR (15); CO (2); RO (2); MY (5); TW (11); KR (13); TH (4); IT (5); TU (11); ES (12); NL (1); SG (2)