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

NCT05927558 | Completed

• 1 other identifier: IMM0123
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Non Hodgkin Lymphoma; Relapse; Refractory Lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of patients in complete response

  Effectiveness of glofitamab in terms of complete response

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with refractory/relapsed B-cell non-Hodgkin lymphoma treated in Italy according to the Compassionate Use Program between March 2022 and September 2023

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (1)

Ematologia Istituto Nazionale Tumori

Milan, Italy

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: December 22, 2023
• Primary Completion: June 24, 2026
• Study Completion: June 24, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IT (1)