Mosunetuzumab for adults with relapsed/refractory follicular lymphoma after at least two prior therapies (compassionate use)
Retrospective, Multicenter Observational Study to Evaluate the Response to Treatment With Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma (FL) After at Least Two Lines of Therapy, Within the Compassionate Use Program (CUP).
This project will see if the antibody drug mosunetuzumab helps adults with follicular lymphoma that has come back or stopped responding after at least two prior treatments when given through a compassionate use program.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | mosunetuzumab |
| Locations | 1 site (Milan) |
| Trial ID | NCT07278921 on ClinicalTrials.gov |
What this trial studies
This is a retrospective, multicenter observational review of medical records from patients with relapsed/refractory follicular lymphoma who received mosunetuzumab through a compassionate use program, led by IRCCS Ospedale San Raffaele in Milan. The analysis focuses on adults who had at least two prior lines of therapy and provided consent for use of their clinical data. Investigators will extract response rates, duration of response, progression-free survival estimates, and recorded adverse events from routine care documentation. No new treatments or visits are required for participants because the work analyzes existing clinical data to describe real-world outcomes.
Who should consider this trial
Good fit: Eligible candidates are adults (>18) with relapsed/refractory follicular lymphoma who received mosunetuzumab via the compassionate use program after at least two prior therapies and agreed to use of their medical data.
Not a fit: Patients under 18, those with other lymphoma types, or people who were not treated with mosunetuzumab through the compassionate use program would not be represented and therefore would not benefit from this analysis.
Why it matters
Potential benefit: If successful, the analysis could show real-world effectiveness and safety of mosunetuzumab in heavily pretreated follicular lymphoma and help support expanded access or future prospective trials.
How similar studies have performed: Previous clinical trials of mosunetuzumab, a CD20xCD3 bispecific antibody, have shown promising response rates in relapsed/refractory follicular lymphoma, so this work complements existing trial data with real-world experience.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years) with follicular non-Hodgkin's lymphoma, undergoing at least two lines of therapy, treated with mosunetuzumab under a compassionate use program. * Patients who have signed informed consent for treatment. Exclusion Criteria: * Age \<18 years * Patients with other types of cancer/lymphoma * Patients not eligible for the Mosunetuzumab compassionate use program
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Andres JM Ferreri, Prof
- Email: ferreri.clinicaltrials@hsr.it
- Phone: 0226439396
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.