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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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, MZL and FL in a real-world setting.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
Universitätsklinikum Salzburg, Klinik für Innere Medizin III
RECRUITING
Salzburg
Germany
Lübecker Onkologische Schwerpunktpraxis
RECRUITING
Lübeck
Contact Information
Primary
Daniel Kummer, Dr.
ariadne@iomedico.com
+49761152420
Time Frame
Start Date:2022-04-26
Estimated Completion Date:2028-08
Participants
Target number of participants:705
Treatments
Waldenström's Macroglobulinemia
75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Chronic Lymphocytic Leukemia
450 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Marginal Zone Lymphoma
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
Follicular Lymphoma
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) in combination with obinutuzumab (Gazyvaro®)