Evaluating Glofitamab for Relapsed/Refractory B-Cell Lymphoma
Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study
This study is testing how well glofitamab works for people with relapsed or refractory B-cell lymphoma who have already tried other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Drugs / interventions | glofitamab |
| Locations | 1 site (Milano) |
| Trial ID | NCT05927558 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of glofitamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma who received treatment through a Compassionate Use Program in Italy. The study will monitor patients for a minimum of 12 months following their last glofitamab administration to determine the rate of complete responses. It involves multiple centers and focuses on gathering real-world data on the drug's anti-lymphoma activity.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have received glofitamab under the Compassionate Use Program and have completed at least one year of observation.
Not a fit: Patients who have not received glofitamab or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of glofitamab for patients with difficult-to-treat lymphoma.
How similar studies have performed: While this approach is based on compassionate use, similar studies evaluating novel therapies in lymphoma have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milano
- Ematologia Istituto Nazionale Tumori — Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.