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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05927558
Enrollment
59
Registered
2023-07-03
Start date
2023-12-22
Completion date
2026-06-24
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Non Hodgkin Lymphoma, Refractory Lymphoma, Relapse

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.

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 months after the last glofitamab administration.

Interventions

None listed

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of patients in complete response6 monthsEffectiveness of glofitamab in terms of complete response

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026