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New hope for elderly lymphoma patients: antibody therapy without harsh chemo

NCT ID NCT05660967

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study tests a drug called epcoritamab, given alone or with another drug (lenalidomide), in elderly patients with a type of lymphoma (DLBCL) who cannot receive standard chemotherapy. The goal is to see how well the treatment shrinks tumors and how safe it is. All 111 participants will receive active treatment, and they have an equal chance of getting epcoritamab alone or the combination.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

111 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2026

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

75 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.

Inclusion Criteria: * Must have newly diagnosed CD20+ large cell lymphoma. * Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: * Being age ≥80 years; AND/OR * Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy. * Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10. * Have Ann Arbor Stage II-IV disease. * Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment). * Have measurable disease as per Lugano criteria. * Have acceptable organ function based on baseline bloodwork. * Must have fresh (preferred) or archival biopsy material at screening. Exclusion Criteria: * Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection. * Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy), * Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: * Major surgery within 4 weeks prior to the first dose of epcoritamab; * Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; * Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; * Live, attenuated vaccines within 30 days prior to initiation of epcoritamab; * Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed); * Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab. * Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture. * Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form. * Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol. * Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS). * Has active hepatitis B virus (HBV) (DNA polymerase chain reaction \[PCR\]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis. * Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment. * Has suspected active or inadequately treated latent tuberculosis. * Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards. Note: Other protocol defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

diffuse 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

  • AUSL Piacenza Ospedale Guglielmo da Saliceto

    Piacenza, Italy

  • AZ Delta

    Roeselare, Belgium

  • AZ Turnhout - Campus Sint-Elisabeth

    Turnhout, Belgium

  • Asan Medical Center

    Seoul, South Korea

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, Italy

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, Italy

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

    Brescia, Italy

  • Azienda sanitaria integrata università di Trieste

    Trieste, Italy

  • CHU Amiens - Hopital Sud

    Salouël, France

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, France

  • CHU Tours - Hôpital Bretonneau

    Tours, France

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, France

  • CHU de Nantes - Hotel Dieu

    Nantes, France

  • Cancer Institute Hospital of JFCR

    Kōtoku, Japan

  • Centrum Medyczne Pratia Poznan

    Skorzewo, Poland

  • Clinica di Ematologia AOU Ospedali Riuniti di Ancona

    Ancona, Ancona, Italy

  • Derriford Hospital

    Plymouth, United Kingdom

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Czechia

  • Fakultni nemocnice v Motole

    Prague, Czechia

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo, Italy

  • Hopital Claude Huriez - CHRU Lille

    Lille, France

  • Hopital de la Conception - APHM

    Marseille, France

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Nuestra Señora de Valme

    Seville, Spain

  • Hospital Universitario Puerta del Mar

    Seville, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hôpital Henri Mondor

    Créteil, France

  • Hôpital Saint-Antoine

    Paris, France

  • Hôpital Saint-Louis

    Paris, France

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, Spain

  • IEO Istituto Europeo di Oncologia Parent

    Milan, Italy

  • IRCCS Centro di Riferimento Oncologico

    Aviano, Italy

  • IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

    Meldola, Italy

  • Institut Jules Bordet

    Anderlecht, Belgium

  • Jeonbuk National University Hospital

    Jeonju, South Korea

  • Kagoshima University Hospital

    Kagoshima, Japan

  • Kanazawa University Hospital

    Kanazawa, Japan

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Kepler Universitätsklinikum

    Linz, Austria

  • Kindai University Hospital

    Ōsaka-sayama, Japan

  • Klinikum Wels-Grieskirchen GmbH

    Wels, Austria

  • Kyushu University Hospital

    Fukuoka, Japan

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, Austria

  • MICS Centrum Medyczne Torun

    Torun, Poland

  • Matsuyama Red Cross Hospital

    Matsuyama, Japan

  • NHO Nagoya Medical Center

    Nagoya, Japan

  • National Cancer Center

    Goyang-si, South Korea

  • National Cancer Center Hospital East

    Kashiwa, Japan

  • Ospedale San Raffaele

    Milan, Italy

  • Pratia MCM Krakow

    Krakow, Poland

  • Royal Cornwall Hospital NHS Trust

    Truro, United Kingdom

  • Royal Marsden Hospital

    Sutton, United Kingdom

  • Royal Marsden Hospital - Fulham

    London, United Kingdom

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Southampton General Hospital

    Southampton, United Kingdom

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188, United States

  • UZ Brussels

    Jette, Belgium

  • UZ Leuven

    Leuven, Belgium

  • Universitaetsklinikum Aachen AOeR

    Aachen, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, Germany

  • Vitaz

    Temse, Belgium

  • Vivantes Klinikum Neukoelln

    Berlin, State of Berlin, Germany

  • Vseobecna fakultni nemocnice v Praze

    Prague, Czechia

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska, Poland

  • Yamagata University Hospital

    Yamagata, Japan

  • ZNA

    Antwerp, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.