Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Stopped early · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Key facts

Study ID

NCT05660967

Run by

Genmab

People needed

111

Starts

2023-03-06

Expected to finish

2026-06-10

Last updated by the study team

2026-07-02

Who can join

Age: 75 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kepler Universitätsklinikum — Linz, Austria
• LKH - Universitätsklinikum der PMU Salzburg — Salzburg, Austria
• Klinikum Wels-Grieskirchen GmbH — Wels, Austria
• Institut Jules Bordet — Anderlecht, Belgium
• ZNA — Antwerp, Belgium
• UZ Brussels — Jette, Belgium
• UZ Leuven — Leuven, Belgium
• AZ Delta — Roeselare, Belgium
• Vitaz — Temse, Belgium
• AZ Turnhout - Campus Sint-Elisabeth — Turnhout, Belgium
• Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
• Fakultni nemocnice v Motole — Prague, Czechia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• CHU Angers - Hôpital Hôtel Dieu — Angers, France
• Hôpital Henri Mondor — Créteil, France
• Hopital Claude Huriez - CHRU Lille — Lille, France
• Hopital de la Conception - APHM — Marseille, France
• CHU de Nantes - Hotel Dieu — Nantes, France
• Hôpital Saint-Antoine — Paris, France
• Hôpital Saint-Louis — Paris, France
• CHU de Bordeaux - Hôpital Haut-Lévêque — Pessac, France
• CHU Amiens - Hopital Sud — Salouël, France
• CHU Tours - Hôpital Bretonneau — Tours, France
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States

Full record on ClinicalTrials.gov

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