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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Percentage of Participants Achieving Overall Response (OR) [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 12 центров

• 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
• … и ещё 4 центра

Греция · 11 центров

• 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
• … и ещё 3 центра

Бельгия · 9 центров

• 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
• … и ещё 1 центр

Великобритания · 8 центров

• 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

Аргентина · 6 центров

• 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

Италия · 6 центров

• 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

Канада · 5 центров

• 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

Болгария · 4 центра

• 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

Австралия · 3 центра

• Nepean Cancer Centre, Nepean Hospital /ID# 277782 — Kingswood
• Calvary Mater Newcastle /ID# 277783 — Waratah
• Cabrini Hospital Malvern /ID# 277780 — Malvern

Израиль · 3 центра

• Tel Aviv Sourasky Medical Center /ID# 271615 — Tel Aviv
• Hadassah Medical Center-Hebrew University /ID# 271616 — Jerusalem
• Rabin Medical Center. /ID# 271614 — Petah Tikva

Австрия · 2 центра

• Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288 — Graz
• Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 273266 — Leoben

Мексика · 2 центра

• Hematologica Alta Especialidad /ID# 275279 — Huixquilucan de Degollado
• Centro de Especialidades Hemato-Oncologicas /ID# 275286 — Mexico City

Португалия · 2 центра

• Unidade Local de Saude de Coimbra, EPE /ID# 272720 — Coimbra
• Unidade Local de Saúde Trás-os-Montes e Alto Douro /ID# 275404 — Vila Real

Идентификаторы

NCT: NCT06830759 · P24-903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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