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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002139-41 | EudraCT Number | ||
| 2024-511747-25-00 | Registry Identifier | CTIS number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FL | Experimental | Follicular lymphoma grade 1-3a cohort |
|
| DLBCL | Experimental | Diffuse large B-cell lymphoma cohort |
|
| MCL | Experimental | Mantle Cell Lymphoma cohort |
|
| MZL | Experimental | Marginal Zone Lymphoma cohort |
|
| Other B-NHL | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odronextamab | Drug | Administered by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR), as assessed by independent central review | FL grade 1-3a/MZL | Up to 52 weeks of study treatment |
| ORR, as assessed by independent central review | DLBCL/MCL/Other B-NHL | Up to 36 weeks of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ORR, as assessed by the local investigator | FL/MZL | Up to 52 weeks of study treatment |
| ORR, as assessed by the local investigator | DLBCL/MCL/Other B-NHL |
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Key Inclusion Criteria:
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)
Disease-specific cohorts:
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate bone marrow, hepatic, and renal function as defined in the protocol
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41766170 | Derived | Villasboas JC, Poon M, Tani M, Jimenez-Ubieto A, Tessoulin B, Warwick L, Brown D, Namuduri M, Lin C, Delwart V, Jagadeesh D. Odronextamab in people with relapsed or refractory follicular lymphoma: plain language summary of the ELM-2 study. Future Oncol. 2026 Mar;22(6):643-658. doi: 10.1080/14796694.2026.2628111. Epub 2026 Mar 1. | |
| 40902079 |
| Label | URL |
|---|---|
| Related Info | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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
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5 cohorts The first 68 patients in the DLBCL cohort will be randomized; the remaining patients will not be randomized
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| Up to 36 weeks of study treatment |
| Complete Response (CR) Rate, as assessed by the local investigator | FL grade 1-3a/MZL | Up to 52 weeks of study treatment |
| CR rate, as assessed by independent central review | FL grade 1-3a/MZL | Up to 52 weeks of study treatment |
| CR rate, as assessed by the local investigator | DLBCL/MCL/Other B-NHL | Up to 36 weeks of study treatment |
| CR rate, as assessed by independent central review | DLBCL/MCL/Other B-NHL | Up to 36 weeks of study treatment |
| Progression-Free Survival (PFS), as assessed by independent central review | Approximately 194 weeks following the first dose |
| PFS, as assessed by the local investigator | Approximately 194 weeks following the first dose |
| Overall Survival (OS) | Approximately 194 weeks following the first dose |
| Duration Of Response (DOR), as assessed by independent central review | Approximately 194 weeks following the first dose |
| DOR, as assessed by the local investigator | Approximately 194 weeks following the first dose |
| Disease Control Rate (DCR), as assessed by independent central review | FL grade 1-3a/MZL | Up to 52 weeks of study treatment |
| DCR, as assessed by the local investigator | FL grade 1-3a/MZL | Up to 52 weeks of study treatment |
| DCR, as assessed by independent central review | DLBCL/MCL/Other B-NHL | Up to 36 weeks of study treatment |
| DCR, as assessed by the local investigator | DLBCL/MCL/Other B-NHL | Up to 36 weeks of study treatment |
| Incidence and severity of Treatment Emergent Adverse Events (TEAEs) | Approximately 194 weeks following the first dose |
| Concentration of odronextamab | End of infusion [EOI]; Concentration at a specified time t [Ct]) | 12 weeks following end of treatment |
| Incidence of Anti-Drug Antibodies (ADA) to odronextamab over time | 12 weeks following end of treatment |
| Titer of anti-drug antibodies to odronextamab over time | 12 weeks following end of treatment |
| Incidence of Neutralizing antibodies (Nab) to odronextamab over time | 12 weeks following end of treatment |
| Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30) | The EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). | Approximately 194 weeks following the first dose |
| Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) | Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS). | Approximately 194 weeks following the first dose |
| Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) | The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Approximately 194 weeks following the first dose |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27257 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Border Medical Oncology | East Albury | New South Wales | 2640 | Australia |
| Northern NSW Local Health District The Tweed Hospital | Tweed Heads | South Wales | 2485 | Australia |
| Epworth Hospital | East Melbourne | Victoria | VIC 3002 | Australia |
| North Building | Frankston | Victoria | 3199 | Australia |
| Andrew Love Cancer Centre | Geelong | Victoria | 3220 | Australia |
| Olivia Newton John Cancer Wellness & Research Centre | Heidelberg | Victoria | VIC 3084 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Cross Cancer Institute | Edmonton | Alberta | T6G172 | Canada |
| QEII Health Science Centre - Halifax location | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research) | Beijing | Beijing Municipality | 100142 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Beijing Municipality | 300020 | China |
| Second Affiliated Hospital - Xinqiao Hospital | Chongqing | Chongqing Municipality | 400000 | China |
| Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| The Affiliated Tumor Hospital | Harbin | Heilongjiang | 150081 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| The First Affiliated Hospital - Soochow University | Suzhou | Jiangsu | 215000 | China |
| The First Bethune Hospital | Changchun | Jilin | 130021 | China |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Shanhai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute | Tianjin | Tianjin Municipality | 300060 | China |
| The First Hospital affiliated to the Medical School of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Peking University - Third Hospital | Beijing | 100191 | China |
| Hopital Haut-Leveque | Pessac | Aquitaine | 33604 | France |
| Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN | Caen | Calvados | 14000 | France |
| Hopital Lyon Sud | Pierre-Bénite | Lyon | 69310 | France |
| Hopital Claude Huriez - CHR Lille | Lille | Nord | 59037 | France |
| CHU Hotel Dieu Service Hematologie | Nantes | Pays de la Loire Region | 44093 | France |
| Chu Poitiers - Pole Regional De Cancerologie | Poitiers | Vienne | 86000 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hospital de la Pitie-Salpetriere | Paris | 75651 | France |
| Unite Hemopathies Lymphoides Hospital Henri Mondor | Créteil | Île-de-France Region | 94010 | France |
| Kliniken Ostalb Stauferklinikum Schwab Gmund | Mutlangen | Gmund | D-73557 | Germany |
| University Hospital Halle Saale | Halle | 6120 | Germany |
| Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin | Würzburg | 97080 | Germany |
| UOC Hematologia, Fondazione IRCCS, Ca Granda, OM Policlinico | Milan | Milan | 20122 | Italy |
| University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale | Bologna | 40138 | Italy |
| Uos Ematologia - Ospedale Civile di Livorno | Livorno | 57124 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology | Milan | 20162 | Italy |
| AOU Maggiore della Carita | Novara | 28100 | Italy |
| Presidio Ospedaliero Santa Maria della Misericordia | Perugia | 6156 | Italy |
| Ospedale Santa Maria delle Croci | Ravenna | 48121 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Ospedale dell'Angelo - Varese | Varese | 21100 | Italy |
| Ospedale DellAngelo Di Mestre | Venice | 30174 | Italy |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | Aichi-ken | 466-8650 | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | Aiti | 460-0001 | Japan |
| Chiba Cancer Center | Chiba | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization National Kyushu Cancer Center | Fukuoka | Hukuoka | 811-1395 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| Tokai University Hospital | Isehara-Shi | Kanagawa | 259-1193 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Osaka Metropolitan University Hospital | Osaka | Osaka | 545-8586 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1298 | Japan |
| National Cancer Center Hospital - Tsukiji Campus | Chuo Ku | Tokyo | 104-0045 | Japan |
| Yamagata University Hospital | Yamagata | Yamagata | 990-9585 | Japan |
| Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki | 852-8511 | Japan |
| Centrum Onkologii Instytut im M Sklodowskiej CurieOddzial Chorob United Kingdomladu Chlonnego | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Uniwersyteckie Centrum | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Pomorskie Hospitals SP. Z O. O. Oncology And Radiotherapy Ward | Gdynia | Pomeranian Voivodeship | 81519 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Szpitale Pomorskie spSp. Z.o.o. | Gdynia | 81-519 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital) | Lodz | 93-513 | Poland |
| Instytut Hematologii I Transfuzjologii Klinika Hematologii | Warsaw | 02-776 | Poland |
| Uniwersytecki Szpital Kliniczny we Wroclawiu, Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych | Wroclaw | 50-367 | Poland |
| National University Hospital | Singapore | 119074 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Icon Soc Farrer Park | Singapore | 217562 | Singapore |
| University of Ulsan College of Medicine | Ulsan | Daegu | 682-714 | South Korea |
| National Cancer Center | Gyeonggi-do | Gyeonggi-do | 10408 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Severance Hospital | Seoul | 3722 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 6591 | South Korea |
| Ewha Womans University Mokdong Hospital - Hemato Oncology | Seoul | 7985 | South Korea |
| Hospital Universitari Son Espases | Palma | Balearic Islands | 07120 | Spain |
| Hospital Son Llatzer | Palma | Balearic Islands | 07198 | Spain |
| Ico Lhospitalet - Hospital Duran i Reynals | Barcelona | Catalonia | 8907 | Spain |
| Hospital Universitario Quiron Salud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona - Planta 4 Escalera | Barcelona | 8036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Chang Gung Memorial Hospital Kaohsiung | Kaohsiung City | 83301 | Taiwan |
| China Medical University | Taichung | 40447 | Taiwan |
| National Cheng Kung University | Tainan | 704 | Taiwan |
| Chi-Mei Medical Center - Liuying | Tainan | 736 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 11251 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| Chang Gung Medical Foundation- | Taoyuan | 333 | Taiwan |
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Derriford Hospital and the Royal Eye Infirmary | Plymouth | Devon | PL6 8DH | United Kingdom |
| The Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Arnason JE, Matasar M, Luminari S, Tucker D, 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 Dec 9;9(23):6130-6140. doi: 10.1182/bloodadvances.2025016332. |
| 40472301 | Derived | 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. |
| 40097657 | Derived | 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. |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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