Clinical trial NCT06830759: Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma
Official title: EpcoReal: A Multi-country, Prospective Observational Study of Epcoritamab in NHL Comprising Two Patient Cohorts (3L+ (D)LBCL and 3L+ FL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B-cell Lymphoma
Follicular Lymphoma
Keywords: Diffuse large B-cell lymphoma
Follicular Lymphoma
Epcoritamab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genmab
First posted: 2025-02-17
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who are being treated with epcoritamab for Diffuse Large B-Cell and Follicular Lymphoma

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Overall Response (OR)
timeFrame: Up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Krankenhaus Der Barmherzigen Brueder Graz /ID# 273288
state: Steiermark
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 271504
state: Alberta
city: Sudbury
country: Canada
facility: Health Sciences North /ID# 274738
state: Ontario
city: Athens
country: Greece
facility: Evangelismos Hospital /ID# 272736
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 272758
state: Attiki
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupoli /ID# 272737
state: Evros
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 272735
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 271614
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: