Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients
NCT Number: NCT06492837
Acronym: FIL_MOZART
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Follicular Lymphoma
Interventions: DRUG: Mosunetuzumab in combination with Zanubrutinib
Sponsor: Fondazione Italiana Linfomi - ETS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2033-09-15
Locations: Fondazione del Piemonte per l'Oncologia - IRCCS, Ematologia, Candiolo, Torino, Italy|AOU SS. Antonio e Biagio e Cesare Arrigo, SCDU Ematologia, Alessandria, Italy|AOU Ospedali Riuniti, Clinica di Ematologia, Ancona, Italy|Azienda Ospedaliera S.Giuseppe Moscati, S.C. Ematologia e Trapianto emopoietico, Avellino, Italy|IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia, Bari, Italy|Policlinico S.Orsola-Malpighi, Istituto di Ematologia "Seragnoli", Bologna, Italy|ASST Spedali Civili di Brescia, Ematologia, Brescia, Italy|Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia, Catania, Italy|Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia, Firenze, Italy|ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milano, Italy|Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia, Milano, Italy|Fondazione IRCCS San Gerardo dei Tintori, Ematologia, Monza, Italy|AOU Maggiore della Carità di Novara, SCDU Ematologia, Novara, Italy|A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia, Palermo, Italy|Azienda USL Piacenza, UOC Ematologia e Centro Trapianti, Piacenza, Italy|Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia, Reggio Emilia, Italy|Ospedale degli Infermi di Rimini, U.O. di Ematologia, Rimini, Italy|Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione, Roma, Italy|A.O.U. Città della Salute e della Scienza di Torino, S.C.Ematologia, Torino, Italy|Ospedale Ca' Foncello, S.C di Ematologia, Treviso, Italy

Summary:
This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R/R FL who have received at least one line of prior systemic therapy.

Primary Outcome Measures: Complete Response Rate (CRR), CRR at the end of the induction therapy, 36 months
Secondary Outcome Measures: Overall Response Rate (ORR), Partial Response (PR) Rate at the end of induction treatment (EOI), ORR and PR Rate at the end of induction treatment (EOI), 36 months|Overall Response Rate (ORR), Partial Response (PR) Rate at the end of maintenance (EOT, end of treatment), ORR and PR Rate at the end of maintenance (EOT, end of treatment), 48 months|Progression Free Survival (PFS), PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death from any cause., 108 months|Overall Survival (OS), OS defined as the time between the start of prephase and death from any cause., 108 months|Duration of Response (DOR), DOR defined as the time from the first documentation of tumor response (CR or PR) to disease progression or death from any cause, 108 months|Duration of Complete Response (DOCR), DOCR defined as the time from the first documentation of tumor complete response to disease progression or death from any cause., 108 months|Time-to-next-treatment (TTNT), TTNT defined as the time between start of prephase and the initiation of the next line of therapy., 108 months|Event free survival (EFS), EFS defined as the time from the start of prephase to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression., 108 months|Frequency and severity of Adverse Events (AEs) and Serious AEs (SAEs), AEs and SAEs classified as per the latest version of CTCAE., 108 months|Frequency and severity of cytokine release syndrome (CRS) and Neurological Adverse Events (NAE), CRS and NAE will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria, 36 months