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 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R1979-HM-22992022-502783-21-00
• Study Type: interventional
• Target: 216
• Locations: 14 countries
• Sites: 81

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 (81)

Hospital Aleman

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

Location

Hospital Britanico de Buenos Aires

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

Location

Instituto Alexander Fleming

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

Location

Fundaleu - Fundacion Para Combatir La Leucemia

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

Location

Hospital Italiano de Buenos Aires

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

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AUR, Argentina

Location

Hospital Alta Complejidad El Cruce

San Juan Bautista, Buenos Aires, B1888AAE, Argentina

Location

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Location

Hospital Privado Universitario de Cordoba

Córdoba, X5016KEH, Argentina

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Olivia Newton John Cancer Wellness & Research Centre

Heidelberg, Victoria, 3084, Australia

Location

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Hospital Sao Rafael

Salvador, Estado de Bahia, 40285-000, Brazil

Location

Ensino e Terapia de Inovacao Clinica Amo (Etica)

Salvador, Estado de Bahia, 41950-640, Brazil

Location

Hospital Sirio Libanes Brasilia

Brasília, Federal District, 70200-730, Brazil

Location

Uopeccan Hospital do Cancer de Cascavel

Cascavel, Paraná, 85806-300, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital de Clinicas de Porto Alegre

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

Location

Centro Gaucho Integrado

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

Location

Amaral Carvalho Hospital

Jaú, São Paulo, 17210-080, Brazil

Location

Instituto Nacional de Cancer Jose Alencar Gomes da Silva

Rio de Janeiro, 20231050, Brazil

Location

Hospital Sirio Libanes

São Paulo, 01308-050, Brazil

Location

A Beneficencia Portuguesa de Sao Paulo, Oncology House

São Paulo, 01321000, Brazil

Location

Instituto D'Or De Pesquisa e Ensino

São Paulo, 04501-000, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

Casa de Saude Santa Marcelina

São Paulo, 08270-070, Brazil

Location

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7650620, Chile

Location

Hospital Pablo Tobon Uribe

Medellín, Antioquia, 050034, Colombia

Location

Clinica Imbanaco

Cali, Valle del Cauca Department, 760042, Colombia

Location

University of Pecs

Pécs, Baranya, 7624, Hungary

Location

Debreceni Egyetem

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Semmelweis University

Budapest, 1088, Hungary

Location

Hospital Sultanah Aminah Jhor Bahru

Johor Bahru, Johor, 80100, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88586, Malaysia

Location

Hospital Ampang

Kuala Lumpur, Selangor, 68000, Malaysia

Location

Subang Jaya Medical Center

Subang Jaya, Selangor, 47500, Malaysia

Location

Coltea Clinical Hospital

Bucharest, Bucharest, 030141, Romania

Location

Ion Chiricuta Oncology Institute

Cluj-Napoca, Cluj, 400015, Romania

Location

National University Hospital Singapore

Singapore, 119074, Singapore

Location

National Cancer Center

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

Location

St. Vincent Hospital - The Catholic University of Korea

Suwon, Gyeonggi-do, 16247, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-Gu, 21565, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Yeouido St. Marys Hospital

Seoul, 07345, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Clinica Universidad de Navarra- Pamplona

Pamplona, 31008, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, Hunan Province, 33305, Taiwan

Location

Changhua Christian Hospital

Changhua, 500-06, Taiwan

Location

Show Chwan Memorial Hospital

Changhua, 50008, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, 83301, Taiwan

Location

Taichung General Veterans Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Sriraj Hospital

Bangkok, 10700, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Ankara University Faculty of Medicine

Mamak, Ankara, 06620, Turkey (Türkiye)

Location

Gazi University

Ankara, Central Anatolia, 06100, Turkey (Türkiye)

Location

VM Medical Park Mersin Hospital

Mezitli, Mersin, 33200, Turkey (Türkiye)

Location

Tekirdag Namik Kemal University Hospital

Tekirdağ, Suleymanpasa, 59100, Turkey (Türkiye)

Location

Sbu Dr.A.Y. Ankara Onkoloji Suam

Ankara, 06100, Turkey (Türkiye)

Location

VKV American Hopital

Istanbul, 34365, Turkey (Türkiye)

Location

Istanbul University

Istanbul, 34418, Turkey (Türkiye)

Location

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Sakarya University Medical Faculty

Sakarya, 54290, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Samsun, 55270, Turkey (Türkiye)

Location

Zonguldak Bulent Ecevit University

Zonguldak, 67600, Turkey (Türkiye)

Location

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

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 29, 2028
• Study Completion (Estimated): May 29, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

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

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