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NCT05927558 Clinical Trial

Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study

Relapse Clinical Trial

Official title:
Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05927558
Other study ID # IMM0123
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 22, 2023
Est. completion date December 2025

Study information
Verified date December 2023
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 months after the last glofitamab administration.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who received glofitamab according to Compassionate Use Program AG42296 2. Age > 18 years 3. Patients who received at least one dose of glofitamab between March 2022 and September 2023 in the context of the compassionate use program and who completed at least 1 year of observation after last glofitamab administration unless the patient died or was lost to follow up 4. Patients who provided their consent according to local regulation to collect their data for study purposes, dead patients or patients lost to follow up for which any attempt has been made to collect their consent, according to local regulation on data privacy Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ematologia Istituto Nazionale Tumori Milano

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients in complete response Effectiveness of glofitamab in terms of complete response 6 months
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