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NCT Number: NCT06830759

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Britanico de Buenos Aires /ID# 274419, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebekah Taylor

CONTACT

[email protected]

(847) 937-8000

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Genmab

Registry information

Official study title

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

Acronym: EpcoReal

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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