Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma
Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) - a Prospective Multicenter Observational Cohort Study
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 and MZL in a real-world setting.
ARIADNE will collect and analyze data of adult patients with WM, CLL, or MZL in need of treatment. The study will explore the medical resource utilization during therapy with zanubrutinib (Brukinsa®). Further aims are to assess effectiveness, safety and tolerability of the treatment as well as treatment satisfaction and biomarkers. These data will be supplemented by the assessment of patient-reported outcomes (PROs)/ health-related quality of life (QoL). Since treatment options for MW, CLL or MZL are limited and the most important factor is to keep or improve QoL of the patients, there is an urge for real-world clinical data of patients treated with zanubrutinib, especially focusing on patients already treated upfront with a BTK inhibitor, older patients and patients with comorbidities.
Medical resource utilization
Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up
Study Arms / Comparison Groups
Description: 75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
April 26, 2022
Primary Completion Date
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) - Signed and dated informed consent form - Treatment with zanubrutinib 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 or MZL - Participation in an interventional clinical trial during zanubrutinib treatment.
18 Years - N/A
Accepts Healthy Volunteers
Jens Kisro, Dr., +49761152420, [email protected]
BeiGene Switzerland GmbH
Jens Kisro, Dr., Principal Investigator, Lübecker Onkologische Schwerpunktpraxis