About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <18 years
Patients with other types of cancer/lymphoma
Patients not eligible for the Mosunetuzumab compassionate use program
Trial population
Descriptive study of the Italian experience with the compassionate use of mosunetuzumab. Sample size: approximately 25 patients
Trial design
Other
Retrospective
Treatments tested in this trial
Mosunetuzumab
DrugAdult 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Disease-free survival (PFS)
Disease-free survival (PFS) at 1 year is evaluated.
Secondary outcomes
OS
The study's secondary objective is to evaluate the overall survival (OS) of the included patients.
rate of toxicity
Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS.
Sponsors and contacts
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Andrés José Maria Ferreri
Lead sponsor
IRCCS San Raffaele
Sponsor institution