Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study
Recruiting
- Conditions
- RelapseB-cell Non Hodgkin LymphomaRefractory Lymphoma
- Registration Number
- NCT05927558
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of patients in complete response 6 months Effectiveness of glofitamab in terms of complete response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ematologia Istituto Nazionale Tumori
🇮🇹Milano, Italy