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SALVAGE TREATMENT WITH GLOFITAMAB IN RELAPSED/REFRACTORY B-NHL: A GIMEMA-FIL STUDY

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05927558
Collaborator
(none)
96
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is an observational multicenter study aimed at assessing the anti-lymphoma activity of glofitamab in relapsed/refractory B cell non-Hodgikin lymphoma patients treated according to the Compassionate Use Program in Italy between March 2022 and September 2023. Patients will be observed for a minimum of 12 minths after the last glofitamab administration.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    96 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    SALVAGE TREATMENT WITH GLOFITAMAB IN PATIENTS AFFECTED BY RELAPSED/REFRACTORY NON HODGKIN B CELL LYMPHOMA: A GIMEMA-FIL STUDY
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients in complete response [6 months]

      Effectiveness of glofitamab in terms of complete response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Patients who received glofitamab according to Compassionate Use Program AG42296

    2. Age > 18 years

    3. Patients who received the first dose of glofitamab between March 2022 and September 2023 and completed the 1 year of observation after last glofitamab administration (if applicable)

    4. Signed Informed Consent, if applicable

    Exclusion Criteria:
    • Inclusion in other glofitamab interventional trials.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gruppo Italiano Malattie EMatologiche dell'Adulto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    ClinicalTrials.gov Identifier:
    NCT05927558
    Other Study ID Numbers:
    • IMM0123
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell

    Study Results

    No Results Posted as of Jul 3, 2023