An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)

What this Trial Is About

This research evaluates the use of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma, a rare type of blood cancer. It is an observational and retrospective study conducted across multiple centers in Italy to assess the drug's effectiveness and safety in real-world clinical practice. The study aims to provide early evidence that will guide future larger studies for this condition. Patients included in this study have already received zanubrutinib under a named patient program between January 2021 and October 2023. Data will be collected from the start of their therapy until six months after the end of treatment, when applicable. The study does not involve any intervention or treatment assignment but observes patients' outcomes under usual care. Participants' medical records will be reviewed for treatment response and safety outcomes, including overall response rate and side effects during and up to 30 days after the last dose. Researchers will monitor outcomes such as duration of response, progression-free survival, overall survival, and disease-free survival over an average period of six months. The study is led by IRCCS Azienda Ospedaliero-Universitaria di Bologna and involves no active treatment administration by the research team.

Study to Assess Effectiveness and Safety of Zanubrutinib for Patients With Marginal Zone Lymphoma Treated in Italy Under the Named Patient Program (NPP)