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New shot shows promise against tough lymphoma in major trial

NCT ID NCT04628494

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares a new immunotherapy called epcoritamab (given as a shot under the skin) to standard chemotherapy for people with diffuse large B-cell lymphoma that has come back or stopped responding to treatment. About 483 participants will be randomly assigned to receive either epcoritamab or one of two chemo regimens. The main goal is to see if epcoritamab helps people live longer. This study is for those who cannot have a stem cell transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epcoritamab (a type of immunotherapy given as a shot under the skin)
What this could lead to
If it works, epcoritamab could offer a new, less intensive treatment option for people with hard-to-treat DLBCL, potentially improving survival without the need for harsh chemotherapy.
What could go wrong
This is a late-stage trial, but epcoritamab is still experimental. It may not work better than standard chemo, and side effects like cytokine release syndrome are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

483 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: 1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis 2. One of the confirmed histologies below with CD20-positivity: 1. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL) 2. "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL 3. FL Grade 3B 4. T-cell/histiocyte-rich large B-cell lymphoma 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2 4. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening 5. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI) 6. Acceptable renal and liver function 7. Life expectancy \>2 months on standard of care treatment Main Exclusion Criteria: 1. Primary Central Nervous System (CNS) tumor or known CNS involvement 2. Any prior therapy with a bispecific antibody targeting CD3 and CD20 3. Major surgery within 4 weeks prior to randomization 4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization 5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization 6. Autologous stem cell transplant (ASCT) within 100 days of randomization 7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization 8. Seizure disorder requiring anti-epileptic therapy 9. Clinically significant cardiac disease

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme

    Sint-Niklaas, Belgium

  • AZ Sint-Jan

    Bruges, Belgium

  • AZ Turnhout, Campus Sint-Elisabeth

    Turnhout, Belgium

  • Aalborg Universitetshospital

    Aalborg, Denmark

  • Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116

    Aarhus, Denmark

  • Admiraal de Ruyter Ziekenhuis

    Goes, Netherlands

  • Albert Schweitzer Ziekenhuis

    Dordrecht, Netherlands

  • Amerikan Hospital

    Istanbul, Turkey (Türkiye)

  • Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43

    Breda, Netherlands

  • Ankara University Medical Faculty

    Ankara, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, South Korea

  • Audrey ALEME

    Amiens, France

  • Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra

    Rome, Italy

  • Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C

    Novara, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste

    Trieste, Italy

  • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)

    Bergamo, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, Italy

  • Belgyógyászati osztály Markhot Ferenc Kórház

    Eger, Hungary

  • Bnai Zion Medical Center

    Haifa, Israel

  • Bravis Ziekenhuis

    Roosendaal, Netherlands

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234, United States

  • CHRU Tours Hôpital Bretonneau

    Tours, France

  • CHRU de Brest - Hospital Morvan

    Brest, France

  • CHU Caen - IHBN

    Caen, France

  • CHU de Bordeaux Hôpital Haut-Lévêque

    Pessac, France

  • CHU de LIMOGES

    Limoges, France

  • CHU de Nantes - Hôtel Dieu

    Nantes, France

  • CHU de Poitiers - Hôpital la Milétrie

    Poitiers, France

  • CHU de Quebec-Universite Laval

    Québec, Canada

  • Calvary Mater Newcastle

    Waratah, Australia

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Hospitalier Rene Dubos

    Pontoise, France

  • Centre Hospitalier de la Côte Basque

    Bayonne, France

  • Centre Léon Bérard

    Lyon, France

  • Centrum Medyczne Pratia Poznan

    Skorzewo, Poland

  • Ch Cornouaille

    Quimper, France

  • Chonbuk National University Hospital

    Geumam, South Korea

  • Chugoku Central Hospital

    Fukuyama, Japan

  • Clinical Research Unit, Roskilde Sygehus

    Roskilde, Denmark

  • Clinical Trials and Research Centre

    Singapore, Singapore

  • Clinique Victor Hugo

    Paris, France

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Community Health Network Cancer Center North

    Indianapolis, Indiana, 46250, United States

  • Concord Repatriation General Hospital

    Concord, Australia

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

    Debrecen, Hungary

  • Derriford Hospital

    Plymouth, United Kingdom

  • Dokuz Eylul University Medical Faculty

    Izmir, Turkey (Türkiye)

  • Dong-A University Hospital

    Busan, South Korea

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, Turkey (Türkiye)

  • Ege University Medical Faculty

    Izmir, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, Netherlands

  • Federal State Budgetary Institution

    Moscow, Russia

  • Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of

    Saint Petersburg, Russia

  • Federal State Budgetary Institution of Science

    Moscow, Russia

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, Hungary

  • Flinders Medical Centre

    Bedford Park, Australia

  • Fondazione IRCCS Policlinico San matteo

    Pavia, Italy

  • Franciscus Gasthuis And Vlietland

    Rotterdam, Netherlands

  • Fujita Health University Hospital

    Toyoake, Japan

  • Fukushima Medical University Hospital

    Fukushima, Japan

  • Gazi University Medical Faculty

    Ankara, Turkey (Türkiye)

  • Groupe Hospitalier de La Rochelle

    La Rochelle, France

  • Guys and St Thomas NHS Foundation Trust

    London, United Kingdom

  • HUS Cancer Center/ Clinical Trial Unit

    Helsinki, Finland

  • Hadassah University Hospital

    Jerusalem, Israel

  • Haematology - University Hospitals Birmingham NHS Foundation Trust

    Birmingham, United Kingdom

  • Hammersmith Hospital

    London, United Kingdom

  • Henry Ford Health System

    Jackson, Michigan, 49201, United States

  • Hokkaido University Hospital

    Hokkaido, Japan

  • Hopital de la Conception APHM

    Marseille, France

  • Hospita Universitario Puerta Del Mar

    Cadiz, Spain

  • Hospital Arnau de Vilanova

    Lleida, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, Spain

  • Hospital Universitario Virgen De Valme

    Seville, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Hôpital Saint-Louis

    Paris, France

  • Hôpital de Jolimont

    La Louvière, Belgium

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, Spain

  • IRCCS Istituto Tumori Giovanni Paolo II Bari

    Bari, Italy

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Icon Cancer Centre Corporate Office

    South Brisbane, Australia

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237, United States

  • Institut Jules Bordet

    Brussels, Belgium

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Poland

  • Iqvia Tibbi Istatistik

    Istanbul, Turkey (Türkiye)

  • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi

    Istanbul, Turkey (Türkiye)

  • Istanbul University Medical Faculty

    Istanbul, Turkey (Türkiye)

  • Istituto Oncologico Europeo

    Milan, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola, Italy

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, Japan

  • Josa Andras Teaching Hospital, Hematology Dept

    Nyíregyháza, Hungary

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Karadeniz Technical University

    Trabzon, Turkey (Türkiye)

  • Karolinska university Hospital

    Stockholm, Sweden

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Keio University Hospital

    Tokyo, Japan

  • Kindai University Hospital

    Ōsaka-sayama, Japan

  • Kyoto University Medical Hospital

    Kyoto, Japan

  • Kyushu University Hospital

    Fukuoka, Japan

  • LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103, United States

  • MMCORC Attn Delaney Anderson

    Saint Louis Park, Minnesota, 55416, United States

  • Matsuyama Red Cross Hospital

    Matsuyama, Japan

  • Md Anderson Cancer Center

    Madrid, Spain

  • Mie University Hospital

    Mie, Japan

  • NHO Nagoya Medical Center

    Nagoya, Japan

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Cancer Center Hospital East

    Kashiwa, Japan

  • National Cancer Centre Singapore

    Singapore, Singapore

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Institute of Oncology

    Budapest, Hungary

  • National Taiwan University Hospital

    Taipei, Taiwan

  • National University Hospital

    Kent Ridge, Singapore

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, United Kingdom

  • North Star Lodge Cancer Center

    Yakima, Washington, 98902, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, United Kingdom

  • Okayama University Hospital

    Okayama, Japan

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, Austria

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Austria

  • Oslo University Hospital location Radium hospital

    Oslo, Norway

  • Ospedale Santa Maria delle Croci

    Ravenna, Italy

  • Oulu university hospital, Department of hematology

    Oulu, Finland

  • Peninsula Private Hospital Clinical Trials Unit

    Frankston, Australia

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Hungary

  • Pratia MCM Kraków

    Krakow, Poland

  • Pratia Onkologia Katowice

    Katowice, Poland

  • Pusan National University Hospital

    Busan, South Korea

  • Pusan National University Hosptial

    Busan, South Korea

  • Rambam Health Care Center

    Haifa, Israel

  • Rijnstate Arnhem

    Arnhem, Netherlands

  • Royal Cornwall Hospital

    Truro, United Kingdom

  • Royal Marsden NHS Foundation Trust (Sutton)

    Sutton, United Kingdom

  • SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo

    Venezia, Italy

  • Samsung Medical Center

    Seoul, South Korea

  • San Raffaele Hospital

    Milan, Italy

  • Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika

    Budapest, Hungary

  • Seoul National University Bundang Hospital

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, Israel

  • Sourasky Medical Center

    Tel Aviv, Israel

  • St. Olavs Hospital HF

    Trondheim, Norway

  • State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr

    Kazan', Russia

  • State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital

    Saint Petersburg, Russia

  • State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl

    Nizhny Novgorod, Russia

  • Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia

    Szeged, Hungary

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tekirdag Namik Kemal University

    Tekirdağ, Turkey (Türkiye)

  • The Catholic University of Korea Seoul St. Marys Hospital

    Seoul, South Korea

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45229, United States

  • Tohoku University Hospital

    Sendai, Japan

  • Tokai University Hospital

    Tokyo, Japan

  • Tri-Service General Hospital

    Taipei, Taiwan

  • TriHealth Cancer Institute- Good Samaritan Hospital

    Cincinnati, Ohio, 45247, United States

  • UZ Brussel

    Jette, Belgium

  • Ulsan University Hospital

    Ulsan, South Korea

  • Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094

    Cologne, Germany

  • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU

    Salzburg, Austria

  • Universitaetsklinikum Essen

    Essen, Germany

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • Universitair Ziekenhuis gasthuisberg Leuven

    Leuven, Belgium

  • University Hospital Southampton

    Southampton, United Kingdom

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Pecs 1st. Internal medicine Clinic Dept. Hematology

    Pécs, Hungary

  • Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie

    Kiel, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, Poland

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdansk, Poland

  • Vejle Hospital

    Vejle, Denmark

  • Virginia Commonwealth University (VCU) Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188, United States

  • Westmead Hospital

    Westmead, Australia

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, Poland

  • Yamagata University Hospital

    Yamagata, Japan

  • ZNA Middelheim

    Antwerp, Belgium

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