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OpenTrials
Active, Not Recruiting

NCT Number: NCT07393204

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Relapsed Diffuse Large B-cell Lymphoma (DLBCL) Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Refractory Diffuse Large B-Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Italy

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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

Sponsors and collaborators

Lead sponsor

Andrés José Maria Ferreri

Other

Registry information

Official study title

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

Acronym: EPKEY_HSR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 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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