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

Recruiting

• Conditions: Diffuse Large B-cell Lymphoma; Follicular Lymphoma

• Registration Number: NCT06830759
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-17
• Study Start: 2025-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2031-09
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Cross Cancer Institute /ID# 271504; 🇨🇦 Edmonton, Alberta, Canada

Health Sciences North /ID# 274738; 🇨🇦 Sudbury, Ontario, Canada

Evangelismos Hospital /ID# 272736; 🇬🇷 Athens, Attiki, Greece

Papageorgiou General Hospital /ID# 272735; 🇬🇷 Thessaloniki, Greece

Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288; 🇦🇹 Graz, Steiermark, Austria

General Hospital of Athens Laiko /ID# 272758; 🇬🇷 Athens, Attiki, Greece

University General Hospital of Alexandroupoli /ID# 272737; 🇬🇷 Alexandroupoli, Evros, Greece

Rabin Medical Center /ID# 271614; 🇮🇱 Petah Tikva, Israel