Relapsed/Refractory Follicular LymphomaMosuOSSHSRNCT07278921
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).
An observational study of Relapsed/Refractory Follicular Lymphoma, run by Andrés José Maria Ferreri at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Follicular Lymphoma
- What is being tested?
- Mosunetuzumab
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Descriptive study of the Italian experience with the compassionate use of mosunetuzumab. Sample size: approximately 25 patients
Who may be able to join
- 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.
Who cannot join
- Age <18 years
- Patients with other types of cancer/lymphoma
- Patients not eligible for the Mosunetuzumab compassionate use program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Prof. Andrés JM Ferreri, 02-2643- 9396, urc.ul@hsr.it
About this study
Official title: 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).
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Being tested
- Mosunetuzumab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosunetuzumabDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year from treatment initiation
Disease-free survival (PFS)
Disease-free survival (PFS) at 1 year is evaluated.
Measured: 1 year after starting treatment (PFS at 1 year)
Secondary outcomes (2)
OS
The study's secondary objective is to evaluate the overall survival (OS) of the included patients.
Measured: 12 month
rate of toxicity
Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrés José Maria Ferreri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278921
- Sponsor's protocol ID
- MosuOSSHSR
- Acronym
- MosuOSSHSR
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07278921
- Acronym / sponsor ID
- MosuOSSHSR / MosuOSSHSR
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Andrés José Maria FerreriUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Descriptive study of the Italian experience with the compassionate use of mosunetuzumab. Sample size: approximately 25 patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Age <18 years
- Patients with other types of cancer/lymphoma
- Patients not eligible for the Mosunetuzumab compassionate use program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosunetuzumabAdult 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 | Drug | – |
Primary outcome
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.
Disease-free survival (PFS)
Time frame: 1 year after starting treatment (PFS at 1 year)
Disease-free survival (PFS) at 1 year is evaluated.
2 secondary outcomes
OS
Time frame: 12 month
rate of toxicity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Follicular Lymphoma, run by Andrés José Maria Ferreri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andres JM Ferreri, Prof (0226439396, ferreri.clinicaltrials@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the response to Mosu (Lugano criteria) (time frame: Up to 1 year from treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.