Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study

IOM-100461

The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.

2022-04-26

2027-04-01

2027-04-01

Recruiting

400

Inclusion Criteria: * Waldenström's macroglobulinemia (all treatment lines) OR * Chronic lymphocytic leukemia (all treatment lines) OR * Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy) * Follicular lymphoma (≥3 treatment line) * Signed and dated informed consent form * Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL * Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC * Treatment decision before inclusion into this non-interventional study * Age ≥18 years. Exclusion Criteria: * Contraindications according to SmPC for patients with WM, CLL, MZL or FL * Participation in an interventional clinical trial during zanubrutinib treatment.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'All patients will be asked to give additional informed consent that their routinely collected biomaterial will be assigned to the decentralized biobank and may be used for future translational research.'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2023-12-08