AzTrials
AzTrials

Diffuse Large B-Cell LymphomaPhase 3EPCORE DLBCL-2NCT05578976

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 3 study testing Epcoritamab, Cyclophosphamide and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 331 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Epcoritamab, Cyclophosphamide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
331 sitesin 31 countries
Study dates
8 Feb 2023to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
  • Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
  • DLBCL, Not Otherwise Specified (NOS).
  • High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
  • T-cell/histiocyte-rich large B-cell lymphoma.
  • Epstein Barr virus-positive DLBCL, NOS.
Show all 17Show fewer
  • Follicular lymphoma Grade 3b.
  • Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
  • Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
  • Availability of archival or fresh or paraffin embedded tissue at Screening.
  • Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
  • Has at least one target lesion defined as:
  • >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
  • Positron emission tomography (PET)-positive on PET-CT scan.
  • Laboratory values meeting the criteria laid out in the protocol.
  • Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Who cannot join

  • History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
  • Clinically significant cardiovascular disease as per the protocol.

Trial locations and contacts

331 sites in 31 countries.

331 sites in 31 countries

United States68 sites

  • University of New Mexico /ID# 227332

    Albuquerque, New Mexico, 87102-4517

  • Presbyterian Kaseman Hospital /ID# 262084

    Albuquerque, New Mexico, 87110

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462

    Ann Arbor, Michigan, 48109

  • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618

    Aurora, Colorado, 80014

  • CBCC Global Research, Inc. /ID# 262037

    Bakersfield, California, 93309

  • University of Maryland, Baltimore /ID# 225421

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital /ID# 225369

    Baltimore, Maryland, 21287

  • Alta Bates Summit Medical Center for Research /ID# 229427

    Berkeley, California, 94705

  • American Oncology Partners of Maryland /ID# 226859

    Bethesda, Maryland, 20817

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014

    Billings, Montana, 59102

  • Roswell Park Cancer Institute /ID# 239127

    Buffalo, New York, 14263

  • MDACC Cooper /ID# 260320

    Camden, New Jersey, 08103-1461

  • Novant Health Presbyterian Medical Center /ID# 227753

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center - West Complex /ID# 225433

    Charlottesville, Virginia, 22903-3363

  • University of Illinois at Chicago /ID# 226889

    Chicago, Illinois, 60607

  • University of Cincinnati /ID# 225374

    Cincinnati, Ohio, 45267

  • OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260790

    Columbus, Ohio, 43214-3908

  • University of Iowa Health Care /ID# 261945

    Des Moines, Iowa, 50314-3017

  • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654

    East Brunswick, New Jersey, 08816

  • Parkview Comprehensive Cancer Center /ID# 227026

    Fort Wayne, Indiana, 46845

  • Orange Coast Memorial Medical Center /ID# 229632

    Fountain Valley, California, 92708

  • Providence - St. Jude Medical Center /ID# 262042

    Fullerton, California, 92835

  • Goshen Center for Cancer Care /ID# 225534

    Goshen, Indiana, 46526

  • East Carolina University - Brody School of Medicine /ID# 225992

    Greenville, North Carolina, 27834

  • Straub Medical Center /ID# 229464

    Honolulu, Hawaii, 96813-3097

  • Houston Methodist Hospital /ID# 258957

    Houston, Texas, 77030

  • University of Mississippi Medical Center /ID# 228045

    Jackson, Mississippi, 39216-4500

  • Duplicate_Cancer Specialists of North Florida /ID# 226826

    Jacksonville, Florida, 32256

  • Millennium Research & Clinical Development /ID# 228284

    Kingwood, Texas, 77339-6008

  • Saddleback Memorial Medical Center /ID# 229631

    Laguna Hills, California, 92653-3689

  • NHO Revive Research Institute, LLC /ID# 261113

    Lincoln, Nebraska, 68506

  • University of Arkansas for Medical Sciences /ID# 225703

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Ct /ID# 228996

    Long Beach, California, 90806-1701

  • Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032

    Los Alamitos, California, 90720-3309

  • University of Southern California /ID# 225443

    Los Angeles, California, 90033

  • University of California, Los Angeles /ID# 226887

    Los Angeles, California, 90095

  • Norton Cancer Institute - St. Matthews /ID# 225420

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research /ID# 227217

    Lubbock, Texas, 79410

  • NYU Langone Hospital - Long Island /ID# 262412

    Mineola, New York, 11501

  • Morristown Medical Center /ID# 239457

    Morristown, New Jersey, 07960-6136

  • Intermountain Medical Center /ID# 231184

    Murray, Utah, 84107-5701

  • New York Cancer and Blood Specialists- New Hyde Park /ID# 265392

    New Hyde Park, New York, 11042

  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141

    New York, New York, 10016-4744

  • New York Cancer and Blood Specialists- Manhattan /ID# 265391

    New York, New York, 10028

  • Icahn School of Medicine at Mount Sinai /ID# 225370

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379

    New York, New York, 10065-6007

  • Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785

    Ocala, Florida, 34474-4445

  • University of Oklahoma, Stephenson Cancer Center /ID# 225556

    Oklahoma City, Oklahoma, 73104-5418

  • Vista Oncology - East Olympia /ID# 229375

    Olympia, Washington, 98506-5028

  • Orlando Health Cancer Institute /ID# 232626

    Orlando, Florida, 32806

  • New York Cancer and Blood Specialists /ID# 261114

    Port Jefferson Station, New York, 11776-8060

  • Kaiser Permanente - Northwest /ID# 225488

    Portland, Oregon, 97227

  • Virginia Commonwealth University Medical Center Main Hospital /ID# 225796

    Richmond, Virginia, 23219

  • Presbyterian Rust Medical Center /ID# 262068

    Rio Rancho, New Mexico, 87124

  • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680

    Saint Louis Park, Minnesota, 55416

  • Southern IL Univ School of Med /ID# 228999

    Springfield, Illinois, 62702

  • Springfield Clinic Main Campus /ID# 262584

    Springfield, Illinois, 62703-2403

  • MultiCare Institute for Research & Innovation /ID# 225432

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center - Tacoma /ID# 265285

    Tacoma, Washington, 98405

  • Baylor Scott & White Medical Center- Temple /ID# 225935

    Temple, Texas, 76508-0001

  • New York Cancer and Blood Specialists- Eastchester, Bronx /ID# 265396

    The Bronx, New York, 10469

  • Duplicate_University of Arizona Cancer Center - North Campus /ID# 227463

    Tucson, Arizona, 85719-1478

  • Carle Cancer Institute /ID# 228338

    Urbana, Illinois, 61801-1645

  • Cancer Center of Kansas /ID# 261983

    Wichita, Kansas, 67214

  • Novant Health Forsyth Medical Center /ID# 228339

    Winston-Salem, North Carolina, 27103

  • UMass Memorial Medical Center /ID# 226939

    Worcester, Massachusetts, 01605

  • Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206

    Ypsilanti, Michigan, 48197-1051

  • Yuma Regional Medical Center Cancer Center /ID# 261527

    Yuma, Arizona, 85364

Other trials in United States

China27 sites

  • The Fifth Medical Center of PLA General Hospital /ID# 230941

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital /ID# 229819

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital /ID# 230975

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University /ID# 239618

    Changchun, Jilin, 130021

  • Fujian Provincial Cancer Hospital /ID# 238430

    Fuzhou, Fujian, 350014

  • Sun Yat-Sen University Cancer Center /ID# 238371

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital /ID# 230945

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 238436

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387

    Hangzhou, Zhejiang, 310003

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 231249

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer hospital /ID# 231388

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital /Id# 241755

    Harbin, Heilongjiang, 150081

  • Shandong Cancer Hospital /ID# 233200

    Jinan, Shandong, 251601

  • The First Affiliated Hospital of Nanchang University /ID# 230399

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital /ID# 233379

    Nanchang, Jiangxi, 330029

  • Fudan University Cancer Hospital /ID# 251516

    Shanghai, Shanghai Municipality, 200032

  • The First Hospital of China Medical University /ID# 233201

    Shenyang, Liaoning, 110001

  • Fourth Hospital of Hebei Medical University /ID# 238656

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University /ID# 232569

    Suzhou, Jiangsu, 215006

  • Shanxi Provincial Cancer Hospital /ID# 250745

    Taiyuan, Shanxi, 030013

  • Tianjin Cancer Hospital /ID# 230974

    Tianjin, Tianjin Municipality, 300000

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904

    Tianjin, Tianjin Municipality, 300020

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital /ID# 232256

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University /ID# 238426

    Xiamen, Fujian, 361003

  • The Affiliated Hospital of Xuzhou Medical College /ID# 233174

    Xuzhou, Jiangsu, 221006

  • Henan Cancer Hospital /ID# 230398

    Zhengzhou, Henan, 450008

Other trials in China

Netherlands26 sites

  • Jeroen Bosch Ziekenhuis /ID# 229765

    's-Hertogenbosch, 5223 GZ

  • Noordwest Ziekenhuisgroep /ID# 230613

    Alkmaar, North Holland, 1815 JD

  • Flevo Ziekenhuis /ID# 229606

    Almere Stad, Flevoland, 1315 RA

  • Meander Medisch Centrum /ID# 229608

    Amersfoort, Utrecht, 3813 TZ

  • Vrije Universiteit Medisch Centrum /ID# 225608

    Amsterdam, North Holland, 1081 HV

  • Olvg /Id# 229761

    Amsterdam, North Holland, 1091 AC

  • Gelre Ziekenhuizen /ID# 229762

    Apeldoorn, Gelderland, 7334 DZ

  • Amphia Ziekenhuis /ID# 229550

    Breda, North Brabant, 4818 CK

  • Deventer Ziekenhuis /ID# 229937

    Deventer, 7416 SE

  • Albert Schweitzer Ziekenhuis /ID# 229560

    Dordrecht, South Holland, 3318 AT

  • Catharina Ziekenhuis /ID# 230465

    Eindhoven, North Brabant, 5623 EJ

  • Maxima Medisch Centrum /ID# 225603

    Eindhoven, North Brabant, 5631 BM

  • Medisch Spectrum Twente /ID# 225610

    Enschede, Overijssel, 7512 KZ

  • Universitair Medisch Centrum Groningen /ID# 225602

    Groningen, Provincie Groningen, 9713 GZ

  • Spaarne Gasthuis, Haarlem Zuid /ID# 229621

    Haarlem, North Holland, 2035 RC

  • Tergooi /ID# 229772

    Hilversum, North Holland, 1213 XZ

  • Dijklander Ziekenhuis /ID# 229900

    Hoorn, North Holland, 1624 NP

  • Medisch Centrum Leeuwarden /ID# 225605

    Leeuwarden, Provincie Friesland, 8934 AD

  • Leids Universitair Medisch Centrum /ID# 225606

    Leiden, South Holland, 2333 ZA

  • Maastricht Universitair Medisch Centrum /ID# 225607

    Maastricht, Limburg, 6229 HX

  • St. Antonius Ziekenhuis /ID# 229901

    Nieuwegein, Utrecht, 3435 CM

  • Canisius-Wilhelmina Ziekenhuis /ID# 231291

    Nijmegen, Gelderland, 6532 SZ

  • Haaglanden Medisch Centrum /ID# 229686

    The Hague, 2512 VA

  • Elisabeth Tweesteden Ziekenhuis /ID# 229773

    Tilburg, North Brabant, 5022 GC

  • Diakonessenhuis /ID# 251793

    Utrecht, Utrecht, 3582 KE

  • Zaans Medisch Centrum /ID# 230614

    Zaandam, North Holland, 1502 DV

Other trials in Netherlands

France23 sites

  • CHU Amiens-Picardie Site Sud /ID# 238347

    Amiens, Somme, 80054

  • Chu Angers /Id# 245931

    Angers, 49933

  • Centre Hospitalier de la Cote Basque /ID# 249143

    Bayonne, Pyrenees-Atlantiques, 64100

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582

    Caen, 14033

  • CHU Clermont-Ferrand /ID# 229283

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 226560

    Créteil, Paris, 94010

  • CHU Dijon /ID# 238345

    Dijon, Cote-d Or, 21000

  • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899

    La Roche-sur-Yon, Vendee, 85000

  • CHU Grenoble - Hopital Michallon /ID# 226128

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 226101

    Lille, Nord, 59037

  • CHU Limoges - Dupuytren 1 /ID# 234235

    Limoges, Franche-Comte, 87042

  • Institut Paoli-Calmettes /ID# 226557

    Marseille, Bouches-du-Rhone, 13009

  • CHU Montpellier - Hopital Saint Eloi /ID# 228191

    Montpellier, Herault, 34295

  • CHU de Nantes, Hotel Dieu -HME /ID# 226125

    Nantes, Pays de la Loire Region, 44000

  • Chu de Nice-Hopital L'Archet Ii /Id# 226127

    Nice, Alpes-Maritimes, 06202

  • Hôpital Saint-Louis /ID# 226126

    Paris, Paris, 75010

  • Hopital Pitie Salpetriere /ID# 238343

    Paris, Île-de-France Region, 75013

  • HCL - Hopital Lyon Sud /ID# 227086

    Pierre-Bénite, Rhone, 69495

  • CHU Poitiers - La miletrie /ID# 226578

    Poitiers, Vienne, 86000

  • CHU de Rennes - PONTCHAILLOU /ID# 228207

    Rennes, Brittany Region, 35000

  • Centre Henri Becquerel /ID# 226103

    Rouen, Seine-Maritime, 76038

  • Institut Curie - site CLCC René Huguenin /ID# 253519

    Saint-Cloud, 92210

  • CHRU Nancy - Hopitaux de Brabois /ID# 226102

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

Japan20 sites

  • National Cancer Center Hospital /ID# 226089

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center /ID# 251622

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital /ID# 226091

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital /ID# 250869

    Fukushima, Fukushima, 960-1295

  • Tokai University Hospital /ID# 251281

    Isehara, Kanagawa, 259-1193

  • Kagoshima University Hospital /ID# 250163

    Kagoshima, Kagoshima-ken, 890-8520

  • Kanazawa University Hospital /ID# 251770

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 250151

    Kashiwa-shi, Chiba, 277-8577

  • Kobe City Medical Center General Hospital /ID# 250597

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital Of JFCR /ID# 230269

    Koto-ku, Tokyo, 135-8550

  • Matsuyama Red Cross Hospital /ID# 251068

    Matsuyama, Ehime, 790-8524

  • NHO Nagoya Medical Center /ID# 230677

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital /ID# 226090

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital /ID# 250161

    Okayama, Okayama-ken, 700-8558

  • Kindai University Hospital /ID# 250160

    Osakasayama-shi, Osaka, 589-8511

  • Duplicate_Hokkaido University Hospital /ID# 250149

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital /ID# 250150

    Sendai, Miyagi, 9808574

  • Duplicate_Osaka University Hospital /ID# 251283

    Suita-shi, Osaka, 565-0871

  • University of Tsukuba Hospital /ID# 251282

    Tsukuba, Ibaraki, 305-8576

  • Yamagata University Hospital /ID# 230003

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Italy16 sites

  • Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 225542

    Alessandria, Alessandria, 15100

  • Duplicate_Centro di Riferimento Oncologico /ID# 225553

    Aviano, Pordenone, 33081

  • I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548

    Bari, Bari, 70124

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 225551

    Bologna, Emilia-Romagna, 40138

  • Duplicate_ASST Spedali civili di Brescia /ID# 225549

    Brescia, Brescia, 25123

  • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751

    Candiolo, Torino, 10060

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 252192

    Meldola, Reggio Emilia, 47014

  • IRCCS Ospedale San Raffaele /ID# 225555

    Milan, Milano, 20132

  • Istituto Europeo Di Oncologia /ID# 225545

    Milan, Milano, 20141

  • Azienda Ospedaliera Universitaria Federico II /ID# 225543

    Naples, Napoli, 80131

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 225541

    Palermo, Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana /ID# 225575

    Pisa, Pisa, 56126

  • Ospedale Santa Maria Delle Croci /ID# 225571

    Ravenna, Ravenna, 48121

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554

    San Giovanni Rotondo, Foggia, 71013

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 225775

    Turin, Piedmont, 10126

Other trials in Italy

Spain16 sites

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 225810

    Barcelona, Barcelona, 08003

  • Hospital Universitario Vall d'Hebron /ID# 225811

    Barcelona, Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 226651

    Barcelona, Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 225813

    Barcelona, Barcelona, 08041

  • Hospital Universitario Reina Sofia /ID# 225806

    Córdoba, Cordoba, 14004

  • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381

    El Palmar, Murcia, 30120

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 227393

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228

    Madrid, Madrid, 28027

  • Hospital Universitario Infanta Leonor /ID# 225816

    Madrid, Madrid, 28031

  • MD Anderson Madrid /ID# 225817

    Madrid, Madrid, 28033

  • Hospital Universitario Ramon y Cajal /ID# 241750

    Madrid, Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 225804

    Madrid, Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 225815

    Madrid, Madrid, 28041

  • Clinica Universidad de Navarra - Pamplona /ID# 225809

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia /ID# 225818

    Valencia, Valencia, 46010

Other trials in Spain

Belgium12 sites

  • Institut Jules Bordet /ID# 225954

    Anderlecht, 1070

  • Duplicate_ZAS Middelheim /ID# 225741

    Antwerp, Antwerpen, 2020

  • ZAS Cadix /ID# 264327

    Antwerp, Antwerpen, 2030

  • AZ Sint-Jan Brugge /ID# 225735

    Bruges, 8000

  • Cliniques Universitaires UCL Saint-Luc /ID# 225737

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 250031

    Ghent, Oost-Vlaanderen, 9000

  • Hospital La Louviere Site Jolimont - Helora /ID# 225738

    La Louvière, Hainaut, 7100

  • Universitair Ziekenhuis Leuven /ID# 225951

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liège /ID# 225952

    Liège, Liege, 4000

  • AZ-Delta /ID# 225736

    Roeselare, West-Vlaanderen, 8800

  • Vitaz /Id# 226153

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 225742

    Yvoir, Namur, 5530

Other trials in Belgium

Brazil10 sites

  • Hospital de Clinicas da Universidade Federal do Parana /ID# 226027

    Curitiba, Paraná, 80060-900

  • Hospital Erasto Gaertner /ID# 262593

    Curitiba, Puerto Rico, 81520-060

  • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065

    Jaú, São Paulo, 17210-070

  • Instituto Nacional de Cancer (INCA) /ID# 226026

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023

    São Paulo, São Paulo, 01323-001

  • Hospital Alemao Oswaldo Cruz /ID# 252833

    São Paulo, São Paulo, 01323-020

  • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 262394

    São Paulo, São Paulo, 01401-002

  • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809

    São Paulo, São Paulo, 01509-900

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048

    São Paulo, São Paulo, 05403-000

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

South Korea10 sites

  • Inje University - Busan Paik Hospital /ID# 232262

    Busan, Busan Gwang Yeogsi, 47392

  • Dong-A University Medical Center /ID# 228451

    Busan, Busan Gwang Yeogsi, 49201

  • Keimyung University Dongsan Hospital /ID# 232264

    Daegu, Gyeongsangbuk-do, 42601

  • Jeonbuk National University Hospital /ID# 232263

    Jeonju, Jeonrabugdo, 54907

  • Seoul National University Bundang Hospital /ID# 225763

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 225760

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 225758

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 225759

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761

    Seoul, Seoul Teugbyeolsi, 06591

  • Ulsan University Hospital /ID# 226971

    Ulsan, Ulsan Gwang Yeogsi, 44033

Other trials in South Korea

Australia8 sites

  • Royal Adelaide Hospital /ID# 225683

    Adelaide, South Australia, 5000

  • Monash Health - Monash Medical Centre /ID# 225680

    Clayton, Victoria, 3168

  • Austin Health /ID# 225716

    Heidelberg, Victoria, 3084

  • Liverpool Hospital /ID# 230072

    Liverpool, New South Wales, 2170

  • The Alfred Hospital /ID# 225999

    Melbourne, Victoria, 3004

  • Hollywood Private Hospital /ID# 251837

    Nedlands, Western Australia, 6009

  • Perth Blood Institute Ltd /ID# 225679

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital /ID# 226583

    Perth, Western Australia, 6000

Other trials in Australia

Hungary8 sites

  • Semmelweis Egyetem /ID# 227239

    Budapest, Budapest, 1085

  • Orszagos Onkologiai Intezet /ID# 227294

    Budapest, 1122

  • Debreceni Egyetem-Klinikai Kozpont /ID# 226821

    Debrecen, Hajdú-Bihar, 4032

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189

    Győr, Győr-Moson-Sopron, 9024

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938

    Kaposvár, Somogy County, 7400

  • Szegedi Tudományegyetem /ID# 226838

    Szeged, Szeged, 6720

  • Tolna Varmegyei Balassa Janos Korhaz /ID# 250063

    Szekszárd, Tolna County, 7100

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846

    Szombathely, Vas County, 9700

Other trials in Hungary

Israel8 sites

  • Rambam Health Care Campus /ID# 225981

    Haifa, H_efa, 3109601

  • Shaare Zedek Medical Center /ID# 259796

    Jerusalem, Jerusalem, 91031

  • Hadassah /ID# 225614

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 225612

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center /ID# 225862

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 225600

    Ramat Gan, Tel Aviv, 5265601

  • Assuta Tel Aviv Medical Center /ID# 226066

    Tel Aviv, Central District, 6971028

  • Tel Aviv Sourasky Medical Center /ID# 225891

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Greece7 sites

  • General Hospital of Athens Laiko /ID# 225399

    Athens, Attica, 11527

  • Alexandra General Hospital /ID# 225402

    Athens, Attica, 11528

  • University General Hospital Attikon /ID# 225401

    Athens, Attica, 12462

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416

    Athens, 10676

  • University General Hospital of Ioannina /ID# 225400

    Ioannina, Ioannina, 45500

  • General University Hospital of Thessaloniki AXEPA /ID# 225398

    Thessaloniki, Thessaloniki, 54636

  • Theageneio Anticancer Hospital /ID# 225516

    Thessaloniki, Thessaloniki, 54639

Other trials in Greece

Croatia6 sites

  • Klinicki bolnicki centar Rijeka /ID# 251811

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Opca bolnica Dr. Josip Bencevic /ID# 251812

    Slavonski Brod, 35000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 250729

    Split, Split-Dalmatia County, 21000

  • Clinical Hospital Dubrava /ID# 251809

    Zagreb, City of Zagreb, 10000

  • Klinicka bolnica Merkur /ID# 252481

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 250709

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Czechia6 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 225953

    Brno, Brno-mesto, 625 00

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 225955

    Hradec Králové, Hradec Kralove, 500 05

  • Fakultni Nemocnice Ostrava /ID# 225957

    Ostrava, Ostrava-mesto, 708 52

  • Fakultni nemocnice Kralovske Vinohrady /ID# 225956

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze /ID# 225396

    Prague, 128 08

  • Duplicate_Fakultni Nemocnice v Motole /ID# 225958

    Prague, 150 00

Other trials in Czechia

Turkey (Türkiye)6 sites

  • Ankara Universitesi Fakultesi /ID# 227331

    Ankara, Ankara, 06620

  • Anadolu Saglik Merkezi /ID# 225777

    Dilovası, Kocaeli, 41455

  • Inonu University Medical Faculty /ID# 226572

    Malatya, 44280

  • Ondokuz Mayis Universitesi /ID# 251247

    Samsun, Samsun, 55139

  • Karadeniz University /ID# 226573

    Trabzon, Trabzon, 61000

  • Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921

    Yüreğir, 01240

Other trials in Turkey (Türkiye)

Canada5 sites

  • William Osler Health System - Brampton Civic Hospital /ID# 250973

    Brampton, Ontario, L6R 3J7

  • Arthur J.E. Child Comprehensive Cancer Centre Pharmacy /ID# 226077

    Calgary, Alberta, T2N 5G2

  • Juravinski Cancer Centre /ID# 226084

    Hamilton, Ontario, L8V 1C3

  • Saskatoon Cancer Centre /ID# 226082

    Saskatoon, Saskatchewan, S7N 4H4

  • BC Cancer - Vancouver /ID# 230573

    Vancouver, British Columbia, V5Z 1L3

Other trials in Canada

Denmark5 sites

  • Aarhus Universitetshospital - Skejby /ID# 226594

    Aarhus, Central Jutland, 8200

  • Rigshospitalet /ID# 226576

    Copenhagen Ø, Capital Region, 2100

  • Odense University Hospital /ID# 226593

    Odense, Region Syddanmark, 5000

  • Roskilde Sygehus /ID# 226597

    Roskilde, Region Sjælland, 4000

  • Sygehus Lillebalt, Vejle /ID# 226592

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Poland5 sites

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • ARS-MEDICAL Sp. z o.o. /ID# 225848

    Piła, Greater Poland Voivodeship, 64-920

  • Aidport Sp. z o.o. /ID# 227236

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723

    Słupsk, Pomeranian Voivodeship, 76-200

Other trials in Poland

South Africa5 sites

  • University of Cape Town /ID# 227802

    Cape Town, Western Cape, 7925

  • Wits Clinical Research /ID# 227799

    Johannesburg, Gauteng, 1864

  • Wits Clinical Research /ID# 227803

    Johannesburg, Gauteng, 1864

  • Haemalife Inc. /ID# 243391

    Kuils River, Western Cape, 7580

  • Alberts Cellular Therapy /ID# 227798

    Pretoria, Gauteng, 0044

Other trials in South Africa

Sweden5 sites

  • Sodra Alvsborgs sjukhus /ID# 228885

    Borås, Västra Götaland County, 501 82

  • Sahlgrenska Universitetssjukhuset /ID# 250089

    Gothenburg, Västra Götaland County, 413 46

  • Linkoping University Hospital /ID# 233521

    Linköping, Östergötland County, 581 85

  • Skane University Hospital Lund /ID# 227285

    Lund, Skåne County, 224 84

  • Karolinska University Hospital Solna /ID# 229284

    Solna, Stockholm County, 171 64

Other trials in Sweden

Austria4 sites

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360

    Salzburg, State of Salzburg, 5020

  • Universitaetsklinikum St. Poelten /ID# 234016

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 252095

    Vienna, State of Vienna, 1090

  • Klinik Ottakring /ID# 243941

    Vienna, State of Vienna, 1160

Other trials in Austria

Bulgaria4 sites

  • UMHAT Sveti Georgi /ID# 245780

    Plovdiv, Plovdiv, 4002

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616

    Sofia, Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 244615

    Sofia, Sofia, 1431

  • SHAT Hematologic Diseases /ID# 250102

    Sofia, Sofia, 1797

Other trials in Bulgaria

Portugal4 sites

  • 2CA-Braga, Hospital de Braga /ID# 249112

    Braga, Braga District, 4710-243

  • IPO Lisboa FG, EPE /ID# 249109

    Lisbon, Lisbon District, 1099-023

  • Unidade Local de Saude de Santa Maria, EPE /ID# 249111

    Lisbon, Lisbon District, 1649-035

  • IPO Porto FG, EPE /ID# 249110

    Porto, Porto District, 4200-072

Other trials in Portugal

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 226670

    Kaohsiung City, Kaohsiung, 833

  • China Medical University Hospital /ID# 226188

    Taichung, Taichung, 40447

  • Taichung Veterans General Hospital /ID# 226674

    Taichung, Taichung, 40705

  • National Cheng Kung University Hospital /ID# 226671

    Tainan, Tainan, 704

Other trials in Taiwan

United Kingdom4 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 229197

    Birmingham, Birmingham, B15 2TH

  • NHS Lothian /ID# 229055

    Edinburgh, EH3 9HE

  • Hammersmith Hospital /ID# 242215

    London, England, W12 0HS

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692

    Norwich, Norfolk, NR4 7UY

Other trials in United Kingdom

Switzerland3 sites

  • Kantonsspital Aarau AG /ID# 229112

    Aarau, Canton of Aargau, 5001

  • Spital Thun /ID# 229499

    Thun, Canton of Bern, 3600

  • KSW Kantonsspital Winterthur /ID# 241631

    Winterthur, Canton of Zurich, 8400

Other trials in Switzerland

New Zealand2 sites

  • Christchurch Hospital /ID# 250993

    Christchurch, Canterbury, 8011

  • North Shore Hospital /ID# 250992

    Takapuna, Auckland, 0622

Other trials in New Zealand

Puerto Rico2 sites

  • Hematology and Oncology Institute /ID# 230054

    Manati, Puerto Rico, 00674

  • Pan American Center for Oncology Trials, LLC /ID# 230052

    Rio Piedras, Puerto Rico, 00935

Other trials in Puerto Rico

Slovakia2 sites

  • Narodny onkologicky ustav /ID# 238847

    Bratislava, Bratislava Region, 833 10

  • Univerzitna nemocnica Martin /ID# 240828

    Martin, Žilina Region, 036 01

Other trials in Slovakia

About this study

Official title: A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

Read more

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Keywords
Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, R-CHOP, Rituximab, EPCORE
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence, Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05578976
Study groupRoleWhat they receive
Epcoritamab and R-CHOPExperimentalParticipants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Receives: Drug: Epcoritamab; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisone
R-CHOP and RituximabExperimentalParticipants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.
Receives: Drug: Cyclophosphamide; Drug: Rituximab; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5

    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.

    Measured: Up to Approximately 46 Months

Secondary outcomes (5)

  1. Number of Participants with PFS

    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.

    Measured: Up to Approximately 46 Months

  2. Number of Participants with Event-free survival (EFS)

    EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.

    Measured: Up to Approximately 46 Months

  3. Percentage of Participants with Complete Remission (CR)

    CR on or after EOT, determined by Lugano 2014 criteria as assessed by IRC.

    Measured: On or After to Approximately 28 Weeks

  4. Overall survival (OS)

    OS is defined as time from randomization until death due to any causes.

    Measured: Up to Approximately 76 Months

  5. Percentage of Participants with Minimal Residual Disease (MRD) Negativity

    The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.

    Measured: Up to Approximately 46 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start8 Feb 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05578976
Sponsor's protocol ID
M20-621
Other IDs
2023-505277-32, 2023
Acronym
EPCORE DLBCL-2
Status last verified
Sep 2026
First submitted
12 Oct 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab, Cyclophosphamide and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 331 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 331 sites in United States, China, Netherlands, France, Japan and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5 (time frame: Up to Approximately 46 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05578976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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