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 Two Lines of Therapy, Within the Compassionate Use Program (CUP).

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07278921

Acronym

MosuOSSHSR

Enrollment

Registered

2025-12-12

Start date

2025-12-01

Completion date

2026-12-31

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Follicular Lymphoma

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).

Interventions

DRUGMosunetuzumab

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the response to Mosu (Lugano criteria)	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)	1 year after starting treatment (PFS at 1 year)	Disease-free survival (PFS) at 1 year is evaluated.

Secondary

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

Countries

Italy

Contacts

CONTACTAndres JM Ferreri, Prof

ferreri.clinicaltrials@hsr.it0226439396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026