A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

NCT ID: NCT03888105

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2028-12-15

Brief Summary

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This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).

The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.

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

* To see if odronextamab works to destroy cancer cells
* Side effects that may be experienced by people taking odronextamab
* How odronextamab works in the body
* How much odronextamab is present in the blood

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

5 cohorts The first 68 patients in the DLBCL cohort will be randomized; the remaining patients will not be randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FL

Follicular lymphoma grade 1-3a cohort

Group Type EXPERIMENTAL

Odronextamab

Intervention Type DRUG

Administered by intravenous (IV) infusion

DLBCL

Diffuse large B-cell lymphoma cohort

Group Type EXPERIMENTAL

Odronextamab

Intervention Type DRUG

Administered by intravenous (IV) infusion

MCL

Mantle Cell Lymphoma cohort

Group Type EXPERIMENTAL

Odronextamab

Intervention Type DRUG

Administered by intravenous (IV) infusion

MZL

Marginal Zone Lymphoma cohort

Group Type EXPERIMENTAL

Odronextamab

Intervention Type DRUG

Administered by intravenous (IV) infusion

Other B-NHL

Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed

Group Type EXPERIMENTAL

Odronextamab

Intervention Type DRUG

Administered by intravenous (IV) infusion

Interventions

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Odronextamab

Administered by intravenous (IV) infusion

Intervention Type DRUG

Other Intervention Names

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REGN1979

Eligibility Criteria

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Inclusion Criteria

1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017)
2. Disease-specific cohorts:

Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
* FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
* DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
* MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
* MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy
* Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Adequate bone marrow, hepatic, and renal function as defined in the protocol

Exclusion Criteria

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI)
2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter
3. History of allogeneic stem cell transplantation, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion
4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent
7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
8. Known hypersensitivity to both allopurinol and rasburicase
9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Site Status

Weill Cornell Medical College New York Presbyterian Hospital

New York, New York, United States

Site Status

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States

Site Status

Border Medical Oncology

East Albury, New South Wales, Australia

Site Status

Northern NSW Local Health District The Tweed Hospital

Tweed Heads, South Wales, Australia

Site Status

Epworth Hospital

East Melbourne, Victoria, Australia

Site Status

North Building

Frankston, Victoria, Australia

Site Status

Andrew Love Cancer Centre

Geelong, Victoria, Australia

Site Status

Olivia Newton John Cancer Wellness & Research Centre

Heidelberg, Victoria, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

QEII Health Science Centre - Halifax location

Halifax, Nova Scotia, Canada

Site Status

Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)

Beijing, Beijing Municipality, China

Site Status

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Institute of Hematology & Blood Diseases Hospital

Tianjin, Beijing Municipality, China

Site Status

Second Affiliated Hospital - Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Site Status

Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

The Affiliated Tumor Hospital

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

The First Affiliated Hospital - Soochow University

Suzhou, Jiangsu, China

Site Status

The First Bethune Hospital

Changchun, Jilin, China

Site Status

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Shanhai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital

Chengdu, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute

Tianjin, Tianjin Municipality, China

Site Status

The First Hospital affiliated to the Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Peking University - Third Hospital

Beijing, , China

Site Status

Hopital Haut-Leveque

Pessac, Aquitaine, France

Site Status

Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN

Caen, Calvados, France

Site Status

Hopital Lyon Sud

Pierre-Bénite, Lyon, France

Site Status

Hopital Claude Huriez - CHR Lille

Lille, Nord, France

Site Status

CHU Hotel Dieu Service Hematologie

Nantes, Pays de la Loire Region, France

Site Status

Chu Poitiers - Pole Regional De Cancerologie

Poitiers, Vienne, France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Hospital de la Pitie-Salpetriere

Paris, , France

Site Status

Unite Hemopathies Lymphoides Hospital Henri Mondor

Créteil, Île-de-France Region, France

Site Status

Kliniken Ostalb Stauferklinikum Schwab Gmund

Mutlangen, Gmund, Germany

Site Status

University Hospital Halle Saale

Halle, , Germany

Site Status

Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin

Würzburg, , Germany

Site Status

UOC Hematologia, Fondazione IRCCS, Ca Granda, OM Policlinico

Milan, Milan, Italy

Site Status

University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

Bologna, , Italy

Site Status

Uos Ematologia - Ospedale Civile di Livorno

Livorno, , Italy

Site Status

ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology

Milan, , Italy

Site Status

AOU Maggiore della Carita

Novara, , Italy

Site Status

Presidio Ospedaliero Santa Maria della Misericordia

Perugia, , Italy

Site Status

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Site Status

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Ospedale dell'Angelo - Varese

Varese, , Italy

Site Status

Ospedale DellAngelo Di Mestre

Venice, , Italy

Site Status

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, Aiti, Japan

Site Status

Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

National Hospital Organization National Kyushu Cancer Center

Fukuoka, Hukuoka, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Tokai University Hospital

Isehara-Shi, Kanagawa, Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

National Cancer Center Hospital - Tsukiji Campus

Chuo Ku, Tokyo, Japan

Site Status

Yamagata University Hospital

Yamagata, Yamagata, Japan

Site Status

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, , Japan

Site Status

Centrum Onkologii Instytut im M Sklodowskiej CurieOddzial Chorob United Kingdomladu Chlonnego

Warsaw, Masovian Voivodeship, Poland

Site Status

Uniwersyteckie Centrum

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Pomorskie Hospitals SP. Z O. O. Oncology And Radiotherapy Ward

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

Szpitale Pomorskie spSp. Z.o.o.

Gdynia, , Poland

Site Status

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

Lodz, , Poland

Site Status

Instytut Hematologii I Transfuzjologii Klinika Hematologii

Warsaw, , Poland

Site Status

Uniwersytecki Szpital Kliniczny we Wroclawiu, Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych

Wroclaw, , Poland

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Icon Soc Farrer Park

Singapore, , Singapore

Site Status

University of Ulsan College of Medicine

Ulsan, Daegu, South Korea

Site Status

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital - Hemato Oncology

Seoul, , South Korea

Site Status

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Site Status

Hospital Son Llatzer

Palma, Balearic Islands, Spain

Site Status

Ico Lhospitalet - Hospital Duran i Reynals

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona - Planta 4 Escalera

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, , Taiwan

Site Status

China Medical University

Taichung, , Taiwan

Site Status

National Cheng Kung University

Tainan City, , Taiwan

Site Status

Chi-Mei Medical Center - Liuying

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation-

Taoyuan District, , Taiwan

Site Status

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Site Status

Derriford Hospital and the Royal Eye Infirmary

Plymouth, Devon, United Kingdom

Site Status

The Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status

University Hospital of Wales

Cardiff, Wales, United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Countries

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United States Australia Canada China France Germany Italy Japan Poland Singapore South Korea Spain Taiwan United Kingdom

References

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Arnason JE, Matasar MJ, Luminari S, Tucker DL, Sun D, Tao W, Zhu YO, Kundu K, Gupta NT, Leary A, Jankovic V, Ambati S, Mohamed H, Chaudhry A, Brouwer-Visser J. Early clearance of circulating tumor DNA and association with odronextamab response in relapsed/refractory FL and DLBCL. Blood Adv. 2025 Sep 3:bloodadvances.2025016332. doi: 10.1182/bloodadvances.2025016332. Online ahead of print.

Reference Type DERIVED
PMID: 40902079 (View on PubMed)

Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274.

Reference Type DERIVED
PMID: 40472301 (View on PubMed)

Kim WS, Kim TM, Cho SG, Jarque I, Iskierka-Jazdzewska E, Poon LM, Prince HM, Zhang H, Cao J, Zhang M, Tessoulin B, Oh SY, Lim F, Carpio C, Tan TD, Ayyappan S, Gutierrez A, Cai J, Ufkin M, Shariff S, Brouwer-Visser J, Chaudhry A, Mohamed H, Ambati S, Walewski J; ELM-2 Investigators. Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial. Nat Cancer. 2025 Mar;6(3):528-539. doi: 10.1038/s43018-025-00921-6. Epub 2025 Mar 17.

Reference Type DERIVED
PMID: 40097657 (View on PubMed)

Related Links

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Other Identifiers

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2017-002139-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-511747-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

R1979-ONC-1625

Identifier Type: -

Identifier Source: org_study_id

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