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).
MosuOSSHSR
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).
1 other identifier
observational
25
1 country
1
Brief Summary
Retrospective, multicenter observational study to evaluate the response to treatment with Mosunetuzumab in relapsed/refractory Follicular Lymphoma (FL) after at least three lines of therapy, within the Compassionate Use Program (CUP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 3, 2026
January 1, 2026
1.1 years
November 21, 2025
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate the response to Mosu (Lugano criteria)
The primary objective of the study is to evaluate the response to mosunetuzumab in patients diagnosed with follicular lymphoma from second-line therapy, within the national compassionate use program (CUP). This response is assessed according to the 2014 Lugano criteria.
Up to 1 year from treatment initiation
Disease-free survival (PFS)
Disease-free survival (PFS) at 1 year is evaluated.
1 year after starting treatment (PFS at 1 year)
Secondary Outcomes (2)
OS
12 month
rate of toxicity
12 months
Interventions
Adult patients (\>18 years) with Follicular Non-Hodgkin Lymphoma, who have undergone at least two lines of therapy, treated with Mosunetuzumab under a compassionate use program
Eligibility Criteria
Descriptive study of the Italian experience with the compassionate use of mosunetuzumab. Sample size: approximately 25 patients
You may qualify if:
- 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.
You may not qualify if:
- Age \<18 years
- Patients with other types of cancer/lymphoma
- Patients not eligible for the Mosunetuzumab compassionate use program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 12, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share