Brief Title
Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma
Official Title
Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) - a Prospective Multicenter Observational Cohort Study
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Medical resource utilization
Secondary Outcome
Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up
Condition
Waldenström's Macroglobulinemia
Intervention
Zanubrutinib
Study Arms / Comparison Groups
Waldenström's Macroglobulinemia
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®)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
300
Start Date
April 26, 2022
Completion Date
April 2027
Primary Completion Date
April 2027
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jens Kisro, Dr., +49761152420, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT05326308
Organization ID
IOM-100461
Responsible Party
Sponsor
Study Sponsor
iOMEDICO AG
Collaborators
BeiGene Switzerland GmbH
Study Sponsor
Jens Kisro, Dr., Principal Investigator, Lübecker Onkologische Schwerpunktpraxis
Verification Date
February 2023