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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06830759

Acronym

EpcoReal

Enrollment

700

Registered

2025-02-17

Start date

2025-03-28

Completion date

2031-09-01

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma, Follicular Lymphoma

Keywords

Diffuse large B-cell lymphoma, Follicular Lymphoma, Epcoritamab

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Overall Response (OR)	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

Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Greece, Israel, Italy, Mexico, Portugal, Spain, United Kingdom

Contacts

CONTACTRebekah Taylor

rebekah.taylor@abbvie.com(847) 937-8000

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results