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

NCT ID: NCT05660967

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2026-06-28

Brief Summary

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.

Detailed Description

This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible.

The trial is designed in two stages:

• Stage 1 which includes a safety run-in phase in each arm
• Stage 2, an expansion of the selected treatment from Stage 1

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epcoritamab monotherapy

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: BIOLOGICAL

Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.

Epcoritamab in combination with lenalidomide

Group Type: EXPERIMENTAL

Epcoritamab

Intervention Type: BIOLOGICAL

Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.

Lenalidomide

Intervention Type: DRUG

Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Interventions

Epcoritamab

Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.

Intervention Type: BIOLOGICAL

Lenalidomide

Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Intervention Type: DRUG

Other Intervention Names

GEN3013; DuoBody®-CD3×CD20; EPKINLY™; Revlimid®

Eligibility Criteria

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

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

Vivantes Klinikum Neukoelln

Berlin, State of Berlin, Germany

Universitaetsklinikum Aachen AOeR

Aachen, , Germany

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Clinica di Ematologia AOU Ospedali Riuniti di Ancona

Ancona, Ancona, Italy

IRCCS Centro di Riferimento Oncologico

Aviano, , Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, , Italy

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

Brescia, , Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, , Italy

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

Meldola, , Italy

IEO Istituto Europeo di Oncologia Parent

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliera Vincenzo Cervello

Palermo, , Italy

AUSL Piacenza Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Azienda sanitaria integrata università di Trieste

Trieste, , Italy

Kyushu University Hospital

Fukuoka, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

Kanazawa University Hospital

Kanazawa, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Cancer Institute Hospital of JFCR

Kōtoku, , Japan

Matsuyama Red Cross Hospital

Matsuyama, , Japan

NHO Nagoya Medical Center

Nagoya, , Japan

Kindai University Hospital

Ōsaka-sayama, , Japan

Yamagata University Hospital

Yamagata, , Japan

Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Biała Podlaska, , Poland

Pratia MCM Krakow

Krakow, , Poland

Centrum Medyczne Pratia Poznan

Skorzewo, , Poland

MICS Centrum Medyczne Torun

Torun, , Poland

Keimyung University Dongsan Hospital

Daegu, , South Korea

National Cancer Center

Goyang-si, , South Korea

Jeonbuk National University Hospital

Jeonju, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, , Spain

Hospital San Pedro de Alcantara

Cáceres, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Nuestra Señora de Valme

Seville, , Spain

Hospital Universitario Puerta del Mar

Seville, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Royal Marsden Hospital - Fulham

London, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Royal Cornwall Hospital NHS Trust

Truro, , United Kingdom

Countries

United States; Austria; Belgium; Czechia; France; Germany; Italy; Japan; Poland; South Korea; Spain; United Kingdom

Other Identifiers

2021-005744-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

jRCT2021230015

Identifier Type: REGISTRY

Identifier Source: secondary_id

1006219

Identifier Type: OTHER

Identifier Source: secondary_id

2023-504832-16-00

Identifier Type: CTIS

Identifier Source: secondary_id

GCT3013-06

Identifier Type: -

Identifier Source: org_study_id