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).

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAndrés José Maria Ferreri

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Mosunetuzumab

    Drug

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year from treatment initiation
2

Disease-free survival (PFS)

Disease-free survival (PFS) at 1 year is evaluated.

Time frame
1 year after starting treatment (PFS at 1 year)

Secondary outcomes

1

OS

The study's secondary objective is to evaluate the overall survival (OS) of the included patients.

Time frame
12 month
2

rate of toxicity

Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andrés José Maria Ferreri

Lead sponsor

IRCCS San Raffaele

Sponsor institution