Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-cell Lymphoma, Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Australia, Austria, Belgium, Bulgaria +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EpcoReal: A Multi-country, Prospective Observational Study of Epcoritamab in NHL Comprising Two Patient Cohorts (3L+ (D)LBCL and 3L+ FL)
Overview
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.
Primary outcome measures
- Percentage of Participants Achieving Overall Response (OR) [Time frame: Up to approximately 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 12 centers
- Complejo Hospitalario Universitario A Coruña /ID# 272040 — A Coruña
- Institut Català d'Oncologia (ICO) - Badalona /ID# 272043 — Badalona
- Hospital Universitari Parc Tauli /ID# 272044 — Sabadell
- Hospital Universitario Reina Sofia /ID# 272051 — Córdoba
- Hospital Costa del Sol /ID# 272431 — Marbella
- Hospital Universitario de Navarra /ID# 272041 — Pamplona
- Hospital Universitario de Valme /ID# 272050 — Seville
- Hospital de Manises /ID# 272046 — Manises
- … and 4 more centers
Greece · 11 centers
- Agios Andreas Hospital Patras /ID# 273629 — Pátrai
- Evangelismos Hospital /ID# 272736 — Athens
- General Hospital of Athens Laiko /ID# 272758 — Athens
- University General Hospital Attikon /ID# 272738 — Athens
- Metaxa Cancer Hospital Of Piraeus /ID# 273623 — Piraeus
- University General Hospital of Alexandroupoli /ID# 272737 — Alexandroupoli
- University Hospital of Ioannina /ID# 272739 — Ioannina
- AHEPA University General Hospital of Thessaloniki /ID# 273633 — Thessaloniki
- … and 3 more centers
Belgium · 9 centers
- Algemeen Ziekenhuis klina /ID# 273405 — Brasschaat
- Universitair Ziekenhuis Brussel /ID# 273403 — Jette
- Centre Hospitalier Epicura - Hornu /ID# 273406 — Boussu
- Grand Hôpital De Charleroi - Notre Dame /ID# 273728 — Charleroi
- Helora /ID# 273726 — La Louvière
- Groupe Sante CHC - Clinique du MontLegia /ID# 273407 — Liège
- Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 273729 — Genk
- Vitaz /Id# 273408 — Sint-Niklaas
- … and 1 more center
United Kingdom · 8 centers
- Milton Keynes Hospital /ID# 272817 — Milton Keynes
- Royal Cornwall Hospital /ID# 272747 — Truro
- Cheltenham General Hospital /ID# 272746 — Cheltenham
- Queen Alexandra Hospital /ID# 272744 — Portsmouth
- NHS Lanarkshire /ID# 276471 — Airdrie
- Nottingham City Hospital /ID# 272753 — Nottingham
- The Christie /ID# 272745 — Manchester
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 272748 — Newcastle upon Tyne
Argentina · 6 centers
- Hospital Britanico de Buenos Aires /ID# 274419 — Ciudad Autonoma de Buenos Aire
- Hospital Universitario Austral /ID# 274393 — Pilar
- Instituto Alexander Fleming /ID# 277284 — Ciudad Autonoma de Buenos Aire
- Hospital Privado Universitario De Córdoba /ID# 274457 — Córdoba
- Hospital Italiano de Buenos Aires /ID# 274418 — Buenos Aires
- Fundacion Argentina contra la Leucemia (FUNDALEU) /ID# 274390 — Buenos Aires
Italy · 6 centers
- IRCCS Ospedale San Raffaele /ID# 274789 — Milan
- Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 274215 — Naples
- A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 275283 — Turin
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274572 — Rome
- I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 274217 — Bari
- Ospedale La Maddalena /ID# 274411 — Palermo
Canada · 5 centers
- Cross Cancer Institute /ID# 271504 — Edmonton
- The Moncton Hospital /ID# 277230 — Moncton
- Eastern Health - General Hospital /ID# 272062 — St. John's
- Health Sciences North /ID# 274738 — Greater Sudbury
- Kingston General Hospital /ID# 272061 — Kingston
Bulgaria · 4 centers
- Umhat Sveti Ivan Rilsky /ID# 274898 — Sofiya
- University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 274893 — Pleven
- Acibadem City Clinic Tokuda University Hospital EAD /ID# 273659 — Sofia
- Specialized Hospital For Active Treatment Of Haematology Diseases /ID# 274955 — Sofia
Australia · 3 centers
- Nepean Cancer Centre, Nepean Hospital /ID# 277782 — Kingswood
- Calvary Mater Newcastle /ID# 277783 — Waratah
- Cabrini Hospital Malvern /ID# 277780 — Malvern
Israel · 3 centers
- Tel Aviv Sourasky Medical Center /ID# 271615 — Tel Aviv
- Hadassah Medical Center-Hebrew University /ID# 271616 — Jerusalem
- Rabin Medical Center. /ID# 271614 — Petah Tikva
Austria · 2 centers
- Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288 — Graz
- Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 273266 — Leoben
Mexico · 2 centers
- Hematologica Alta Especialidad /ID# 275279 — Huixquilucan de Degollado
- Centro de Especialidades Hemato-Oncologicas /ID# 275286 — Mexico City
Portugal · 2 centers
- Unidade Local de Saude de Coimbra, EPE /ID# 272720 — Coimbra
- Unidade Local de Saúde Trás-os-Montes e Alto Douro /ID# 275404 — Vila Real
Identifiers
NCT: NCT06830759 · P24-903