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)

January 30, 2026 updated by: Andrés José Maria Ferreri

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).

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Prof. Andrés JM Ferreri
          • Phone Number: 02-2643- 9396
          • Email: urc.ul@hsr.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Descriptive study of the Italian experience with the compassionate use of mosunetuzumab.

Sample size: approximately 25 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the response to Mosu (Lugano criteria)
Time Frame: Up to 1 year from treatment initiation
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)
Time Frame: 1 year after starting treatment (PFS at 1 year)
Disease-free survival (PFS) at 1 year is evaluated.
1 year after starting treatment (PFS at 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 12 month
The study's secondary objective is to evaluate the overall survival (OS) of the included patients.
12 month
rate of toxicity
Time Frame: 12 months
Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrés José Maria Ferreri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MosuOSSHSR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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