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

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

NCT ID: NCT05927558

Condition: B-cell Non Hodgkin Lymphoma
Relapse
Refractory Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

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.

Criteria for eligibility:

Study pop:
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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: Ematologia Istituto Nazionale Tumori

Address:
City: Milano
Country: Italy

Status: Recruiting

Contact:
Last name: Paolo Corradini

Start date: December 22, 2023

Completion date: December 2025

Lead sponsor:
Agency: Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class: Other

Source: Gruppo Italiano Malattie EMatologiche dell'Adulto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05927558