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
NCT ID: NCT06230224
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
216 participants
INTERVENTIONAL
2024-02-15
2027-05-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Odronextamab
Participants will receive odronextamab monotherapy.
Odronextamab
Administered by intravenous (IV) infusion
Standard Of Care
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).
Etoposide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Rituximab
Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.
Dexamethasone
Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.
Cisplatin
Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.
Cytarabine
Administered by IV infusion, as part of the DHAP ± R salvage therapy.
Gemcitabine
Administered by IV infusion, as part of the GDP ± R salvage therapy.
Ifosfamide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Carboplatin
Administered by IV infusion, as part of the ICE ± R salvage therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Etoposide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Rituximab
Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.
Dexamethasone
Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.
Cisplatin
Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.
Cytarabine
Administered by IV infusion, as part of the DHAP ± R salvage therapy.
Gemcitabine
Administered by IV infusion, as part of the GDP ± R salvage therapy.
Odronextamab
Administered by intravenous (IV) infusion
Ifosfamide
Administered by IV infusion, as part of the ICE ± R salvage therapy
Carboplatin
Administered by IV infusion, as part of the ICE ± R salvage therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. 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 \[MRI\])
4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Adequate hematologic and organ function.
Exclusion Criteria
2. History of or current relevant CNS pathology, as described in the protocol
3. 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
4. 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
5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
6. Allergy/hypersensitivity to study drug, or excipients.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Britanico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fundaleu - Fundacion Para Combatir La Leucemia
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Olivia Newton John Cancer Wellness & Research Centre
Heidelberg, Victoria, Australia
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, , Brazil
Hospital Sirio Libanes
São Paulo, , Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, , Brazil
Instituto D'Or De Pesquisa e Ensino
São Paulo, , Brazil
Casa de Saude Santa Marcelina
São Paulo, , Brazil
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
University of Pecs
Pécs, Baranya, Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
AOU Maggiore della Carita
Novara, , Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, , Italy
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Hospital Ampang
Kuala Lumpur, Selangor, Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia
Erasmus University Medical Center
Rotterdam, , Netherlands
Ion Chiricuta Oncology Institute
Cluj-Napoca, Cluj, Romania
National University Hospital Singapore
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
National Cancer Center
Gyeonggi-do, Gyeonggi-do, South Korea
St. Vincent Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu, South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Yeyungnam University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul St Marys Hospital
Seoul, , South Korea
Yeouido St. Marys Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Hospital Universitari Son Espases
Palma, Balearic Islands, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Virgen De Las Nieves De Granada
Granada, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
University Hospital Doctor Peset
Valencia, , Spain
Chang Gung Medical Foundation
Chiayi City, Chianan Plain, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, Hunan Province, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Show Chwan Memorial Hospital
Changhua, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
Taichung General Veterans Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chulalongkorn University
Bangkok, , Thailand
Sriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Ankara University Faculty of Medicine
Mamak, Ankara, Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Sbu Dr.A.Y. Ankara Onkoloji Suam
Ankara, , Turkey (Türkiye)
Istanbul University
Istanbul, , Turkey (Türkiye)
Ege University
Izmir, , Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, , Turkey (Türkiye)
Ondokuz Mayıs University
Samsun, , Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
OLYMPIA
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-502783-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R1979-HM-2299
Identifier Type: -
Identifier Source: org_study_id