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

NCT07393204 | Active Not Recruiting

• 1 other identifier: EPKEY_HSR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed Diffuse Large B-cell Lymphoma (DLBCL); Refractory Diffuse Large B-Cell Lymphoma

Keywords

DLBCL; relapsed; refractory

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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 Outcomes (11)

• Adverse Event according to CTCAE v5.0

  through study completion, an average of 1 year

• Incidence and Severity of Cytokine Release Syndrome (CRS)

  through study completion, an average of 1 year

• Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

  through study completion, an average of 1 year

• Complete Response rate

  through study completion, an average of 1 year

• Duration of Response

  through study completion, an average of 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Andrés José Maria Ferreri: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Lymphoma Unit

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 6, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

IT (1)