Italian Real-World Study of Epcoritamab in Relapsed or Refractory DLBCL (EPKEY_HSR)

January 30, 2026 updated by: Andrés José Maria Ferreri

Italian Real-world Study on Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study is expected to include approximately 150 patients. Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024)
  • Received at least one dose of epcoritamab
  • Free and voluntary written informed consent

Exclusion Criteria:

  • Age < 18 years
  • Patients who received epcoritamab outside the Cnn program (e.g., open access program, compassionate use, off-label, prospective trials).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Epcoritamab treatment
Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event according to CTCAE v5.0
Time Frame: through study completion, an average of 1 year
rate and severity of AEs (Adverse Event), AESIs (adverse events of special interest) and SAEs (Serious Adverse Event) according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0)
through study completion, an average of 1 year
Incidence and Severity of Cytokine Release Syndrome (CRS)
Time Frame: through study completion, an average of 1 year
Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria
through study completion, an average of 1 year
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time Frame: through study completion, an average of 1 year
ICANS graded according to ASTCT ICANS grading criteria (ICE score)
through study completion, an average of 1 year
Complete Response rate
Time Frame: through study completion, an average of 1 year
CR rate defined as the proportion of patients with CR, according to Lugano Criteria at 1, 2, 3, 6, 9 and 12 months since treatment start
through study completion, an average of 1 year
Duration of Response
Time Frame: through study completion, an average of 1 year
DoR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier.
through study completion, an average of 1 year
Duration of Complete Response
Time Frame: through study completion, an average of 1 year
DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier.
through study completion, an average of 1 year
Progression Free Survival
Time Frame: through study completion, an average of 1 year
PFS is defined as the time from the start of the treatment to first documented PD or death due to any cause, whichever occurs earlier.
through study completion, an average of 1 year
Overall Survival
Time Frame: through study completion, an average of 1 year
OS is defined as the time from the start of epcoritamab treatment to death
through study completion, an average of 1 year
Time To Next Treatment
Time Frame: through study completion, an average of 1 year
TTNT is defined as duration from treatment initiation to the start of new anti-lymphoma therapy or death due to PD, whichever occurs earlier
through study completion, an average of 1 year
Duration of Treatment
Time Frame: through study completion, an average of 1 year
Duration of Treatment (DoT) is defined as the time from the start of the treatment to discontinuation or death due to any cause, whichever occurs earlier.
through study completion, an average of 1 year
Health Care Resource Utilization (HCRU)
Time Frame: through study completion, an average of 1 year
Health Care Resource Utilization (HCRU) as number and duration of unplanned hospitalizations during treatment and follow-up, number of hematological visits, load of diagnostic exams
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrés José Maria Ferreri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPKEY_HSR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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