Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma (EpcoReal)

February 12, 2026 updated by: AbbVie

EpcoReal: A Multi-country, Prospective Observational Study of Epcoritamab in NHL Comprising Two Patient Cohorts (3L+ (D)LBCL and 3L+ FL)

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections) and the most common type of non-Hodgkin lymphoma. Follicular Lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the real-world effectiveness of subcutaneous epcoritamab in adult participants with advanced DLBCL and FL.

Epcoritamab is an investigational drug being developed for treating participants with DLBCL and FL. Approximately 700 participants will be enrolled in approximately 80 sites across 12-20 countries globally.

Participants will receive epcoritamab as prescribed by their physician in accordance with local country label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1227
        • Recruiting
        • Fundacion Argentina contra la Leucemia (FUNDALEU) /ID# 274390
      • Buenos Aires, Argentina, 1181
        • Recruiting
        • Hospital Italiano de Buenos Aires /ID# 274418
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1280
        • Recruiting
        • Hospital Britanico de Buenos Aires /ID# 274419
      • Pilar, Buenos Aires, Argentina, 1629
        • Recruiting
        • Hospital Universitario Austral /ID# 274393
    • Buenos Aires F.D.
      • Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1426
        • Recruiting
        • Instituto Alexander Fleming /ID# 277284
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5016
        • Recruiting
        • Hospital Privado Universitario De Córdoba /ID# 274457
  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Recruiting
        • Nepean Cancer Centre, Nepean Hospital /ID# 277782
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle /ID# 277783
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Hospital Malvern /ID# 277780
  • Austria
    • Styria
      • Graz, Styria, Austria, 8020
        • Recruiting
        • Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288
      • Leoben, Styria, Austria, 8700
        • Recruiting
        • Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 273266
  • Belgium
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Recruiting
        • Algemeen Ziekenhuis klina /ID# 273405
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel /ID# 273403
    • Hainaut
      • Boussu, Hainaut, Belgium, 7301
        • Recruiting
        • Centre Hospitalier Epicura - Hornu /ID# 273406
      • Charleroi, Hainaut, Belgium, 6000
        • Recruiting
        • Grand Hôpital De Charleroi - Notre Dame /ID# 273728
      • La Louvière, Hainaut, Belgium, 7100
        • Recruiting
        • Helora /ID# 273726
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Groupe Sante CHC - Clinique du MontLegia /ID# 273407
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 273729
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Recruiting
        • Vitaz /Id# 273408
    • West-Vlaanderen
      • Ostend, West-Vlaanderen, Belgium, 8400
        • Recruiting
        • AZ Oostende /ID# 273714
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 274893
      • Sofia, Bulgaria, 1756
        • Recruiting
        • Specialized Hospital For Active Treatment Of Haematology Diseases /ID# 274955
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Tokuda University Hospital EAD /ID# 273659
    • Sofia
      • Sofiya, Sofia, Bulgaria, 1606
        • Recruiting
        • Umhat Sveti Ivan Rilsky /ID# 274898
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute /ID# 271504
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital /ID# 277230
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Eastern Health - General Hospital /ID# 272062
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North /ID# 274738
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston General Hospital /ID# 272061
  • Greece
      • Ioannina, Greece, 45500
        • Recruiting
        • University Hospital of Ioannina /ID# 272739
      • Thessaloniki, Greece, 56429
        • Recruiting
        • Papageorgiou General Hospital /ID# 272735
      • Thessaloniki, Greece, 57010
        • Recruiting
        • General Hospital Of Thessaloniki G. Papanikolaou /ID# 275323
      • Thessaloniki, Greece, 54636
        • Recruiting
        • AHEPA University General Hospital of Thessaloniki /ID# 273633
        • Contact:
          • Site Coordinator
          • Phone Number: +30 231 330 3110
      • Thessaloniki, Greece, 54642
        • Recruiting
        • General Hospital of Thessaloniki Hippokrateio /ID# 273635
        • Contact:
          • Site Coordinator
          • Phone Number: +30 2313312672
    • Achaia
      • Pátrai, Achaia, Greece, 26335
        • Recruiting
        • Agios Andreas Hospital Patras /ID# 273629
        • Contact:
          • Site Coordinator
          • Phone Number: +30 2613601130
    • Attica
      • Athens, Attica, Greece, 10676
        • Recruiting
        • Evangelismos Hospital /ID# 272736
      • Athens, Attica, Greece, 11527
        • Recruiting
        • General Hospital of Athens Laiko /ID# 272758
        • Contact:
          • Site Coordinator
          • Phone Number: +30 213 2061702
      • Athens, Attica, Greece, 12462
        • Recruiting
        • University General Hospital Attikon /ID# 272738
      • Piraeus, Attica, Greece, 18537
        • Recruiting
        • Metaxa Cancer Hospital Of Piraeus /ID# 273623
        • Contact:
          • Site Coordinator
          • Phone Number: +30 213 2079100
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Recruiting
        • University General Hospital of Alexandroupoli /ID# 272737
  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 271616
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center. /ID# 271614
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 271615
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 274217
      • Palermo, Italy, 90146
        • Recruiting
        • Ospedale La Maddalena /ID# 274411
    • Milano
      • Milan, Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele /ID# 274789
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 274215
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 275283
    • Roma
      • Rome, Roma, Italy, 00133
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274572
  • Mexico
      • Huixquilucan de Degollado, Mexico, 52787
        • Recruiting
        • Hematologica Alta Especialidad /ID# 275279
      • Mexico City, Mexico, 11520
        • Recruiting
        • Centro de Especialidades Hemato-Oncologicas /ID# 275286
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Unidade Local de Saude de Coimbra, EPE /ID# 272720
      • Vila Real, Portugal, 5000-185
        • Recruiting
        • Unidade Local de Saúde Trás-os-Montes e Alto Douro /ID# 275404
        • Contact:
          • Site Coordinator
          • Phone Number: +351259300500
  • Spain
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario De Burgos /ID# 272066
      • Murcia, Spain, 30008
        • Recruiting
        • Hospital General Universitario Morales Meseguer /ID# 272466
      • Santa Cruz de Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Señora de Candelaria /ID# 272413
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid /ID# 272042
    • A Coruna
      • A Coruña, A Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña /ID# 272040
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona /ID# 272043
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli /ID# 272044
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia /ID# 272051
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol /ID# 272431
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra /ID# 272041
    • Sevilla
      • Seville, Sevilla, Spain, 41014
        • Recruiting
        • Hospital Universitario de Valme /ID# 272050
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Recruiting
        • Hospital de Manises /ID# 272046
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie /ID# 272745
      • Newcastle upon Tyne, United Kingdom, NE3 3HD
        • Recruiting
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 272748
    • Buckinghamshire
      • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
        • Recruiting
        • Milton Keynes Hospital /ID# 272817
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LQ
        • Recruiting
        • Royal Cornwall Hospital /ID# 272747
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Recruiting
        • Cheltenham General Hospital /ID# 272746
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Recruiting
        • Queen Alexandra Hospital /ID# 272744
    • North Lanarkshire
      • Airdrie, North Lanarkshire, United Kingdom, ML6 0JS
        • Recruiting
        • NHS Lanarkshire /ID# 276471
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital /ID# 272753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants who are being treated with epcoritamab for Diffuse Large B-Cell and Follicular Lymphoma

Description

Inclusion Criteria:

  • Participants who are scheduled to be treated with epcoritamab for Treatment after two or more prior lines of therapy 3L+ diffuse large B-cell lymphoma ((D)LBCL) or 3L+ Follicular lymphoma (FL).
  • Treatment with epcoritamab should be administered in accordance with the approved local label in the participating country.
  • The decision to treat the participant should have been made by the clinician prior to, and independently of any decision to approach the participant to participate in this study.

Exclusion Criteria:

  • Any condition included in the contraindications section of the approved local epcoritamab label in the participating country.
  • Participation in a concurrent interventional clinical trial (not including non-interventional/ observational study, PMOS, or registry participation) from enrollment and throughout the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Epcoritamab
Participants will receive epcoritamab as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Overall Response (OR)
Time Frame: Up to approximately 3 years
Defined as the percentage of participants who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Genmab

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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