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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ematologia Istituto Nazionale Tumori

Milan, Italy

About this study

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.

Who can participate

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

Inclusion criteria

Patients who received glofitamab according to Compassionate Use Program AG42296
Age > 18 years
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
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

Treatment and study plan

Primary outcomes

Rate of patients in complete response

Time frame: 6 months

Effectiveness of glofitamab in terms of complete response

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jul 3, 2023
Registry last updated: Jul 28, 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.

Published trials that share one or more normalized conditions with this study.

Completed