Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492837
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
Brief Title:
Study With Mosunetuzumab and Zanubrutinib in RR Follicular Lymphoma Patients
Sponsor:
Fondazione Italiana Linfomi - ETS
Organization:
Fondazione Italiana Linfomi - ETS
Study Overview
Official Title:
A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib BGB-3111 in RelapsedrefracTory Follicular Lymphoma Patients MOZART
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIL_MOZART
Brief Summary:
This is a Phase 2 multicenter study evaluating the efficacy and safety of mosunetuzumab zanubrutinib MZ used as salvage strategy in patients with RR FL who have received at least one line of prior systemic therapy
Detailed Description:
Eligible patients receive a pre-phase with oral zanubrutinib followed by an induction phase with mosunetuzumab combined with oral zanubrutinib
Patients responsive to induction phase with MZ C1-12 and achieving at least SD will receive maintenance with zanubrutinib for additional 12 months C13-24
There will be an initial safety run-in SRI phase of 10 patients which will be closely monitored for the observed toxicities during the first three cycles of induction from C1D1 to C3D28 No patients will be further enrolled until SRI analyses is completed
If no unexpected toxicity has been observed subsequent patients will be monitored only for patient informed consent grade 3-5 toxicities and SAEs as well as remission status
Safety data will be evaluated by an independent data safety monitoring board DSMB that will advise the principal investigators on the continuation of the study Safety events will be analyzed and compared with the previously described safety profile of mosunetuzumab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants
Patients responsive to induction phase with MZ C1-12 and achieving at least SD will receive maintenance with zanubrutinib for additional 12 months C13-24
There will be an initial safety run-in SRI phase of 10 patients which will be closely monitored for the observed toxicities during the first three cycles of induction from C1D1 to C3D28 No patients will be further enrolled until SRI analyses is completed
If no unexpected toxicity has been observed subsequent patients will be monitored only for patient informed consent grade 3-5 toxicities and SAEs as well as remission status
Safety data will be evaluated by an independent data safety monitoring board DSMB that will advise the principal investigators on the continuation of the study Safety events will be analyzed and compared with the previously described safety profile of mosunetuzumab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None