Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma
NCT Number: NCT06569680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Extranodal Marginal Zone Lymphoma
Interventions: DRUG: Mosunetuzumab
Sponsor: Izidore Lossos, MD
Collaborators: Genentech, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2030-12-01
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.

Primary Outcome Measures: Complete Response (CR) Rate, The number of participants with best overall response of complete response (CR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening Fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) (FDG PET/CT) demonstrated FDG-avid disease., Up to 12 months
Secondary Outcome Measures: Overall Response Rate (ORR), The number of participants with best overall response of complete response (CR) or partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease., Up to 12 months|Partial Response (PR) Rate, The number of participants with partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease., Up to 12 months|Number of Participants Experiencing treatment-related adverse events, The number of participants experiencing toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs), and serious adverse events (SAEs) regardless of attribution. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5., Up to 13 months|Number of Participants Experiencing Cytokine Release Syndrome Adverse Events, The number of participants experiencing cytokine release syndrome (CRS) related adverse events (AEs) will be reported. CRS AEs will be assessed according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus 2019 Grading Criteria., Up to 13 months|Progression-Free Survival (PFS), PFS is the elapsed time from start of treatment to documented progressive disease or death from any cause. For participants alive and progression-free, follow-up will be censored at the last date of document progression-free status., Up to 2 years|Time to Response (TTR), Time to response (TTR) is defined as elapsed time from start of treatment to achievement of complete response (CR) or partial response (CR)., Up to 2 years|Duration of Response (DOR), Duration of response (DOR) is the elapsed time from achievement of objective response (CR or PR) to progression, relapse, or death from any cause., Up to 2 years|Overall Survival (OS), Overall survival (OS) is the elapsed time from start of treatment to death from any cause. Alive participants will be censored at last date known to be alive., Up to 3 years