Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year from treatment initiation |
| Disease-free survival (PFS) | Disease-free survival (PFS) at 1 year is evaluated. | 1 year after starting treatment (PFS at 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The study's secondary objective is to evaluate the overall survival (OS) of the included patients. | 12 month |
| rate of toxicity | Analyze the rate of toxicity recorded during therapy, with particular attention to infusion reactions, CRS, and ICANS. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Descriptive study of the Italian experience with the compassionate use of mosunetuzumab.
Sample size: approximately 25 patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andres JM Ferreri, Prof | Contact | 0226439396 | ferreri.clinicaltrials@hsr.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided