Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of Patients With Waldenström's Macroglobulinemia (WM) Treated in Italy According to the Zanubrutinib (Brukinsa®) Compassionate Use Program (CUP) and in Common Practice Following Commercial Approval.

Launched by FONDAZIONE ITALIANA LINFOMI - ETS · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how patients with Waldenström's Macroglobulinemia (WM), a type of blood cancer, are treated in Italy. Specifically, it looks at patients who received a medication called zanubrutinib (Brukinsa®) through a special program before it became widely available. The goal is to understand how effective this treatment has been and how it is managed by healthcare providers.

To participate in this study, individuals must be at least 18 years old, have a confirmed diagnosis of WM that needs treatment, and have received zanubrutinib either through the Compassionate Use Program or after it was commercially approved. Participants will not be given any new treatments during the study; instead, the research will focus on their past and current treatment experiences. It's important to note that the study is not yet recruiting participants, and patients must provide informed consent to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed and dated informed consent form
• • Waldenström's macroglobulinemia diagnosis in need of treatment according to ESMO (European Society for Medical Oncology) guideline 2018
• • Patients who received Zanubrutinib according to the Italian CUP or in common practice following Zanubrutinib commercial approval
• • Treatment with zanubrutinib according to current SmPC (Summary of Product Characteristics)
• • Treatment decision before inclusion into this non-interventional study
• • Age ≥18 years
• Exclusion Criteria:
• • Contraindications according to SmPC for patients with WM
• • Participation in an interventional clinical trial during zanubrutinib treatment
• • Patients with disease progression during a BTKi treatment (if pre-treated with BTK, only those intolerants are considered eligible)