Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
NCT ID: NCT05326308
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
705 participants
OBSERVATIONAL
2022-04-26
2028-08-31
Brief Summary
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Detailed Description
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Since treatment options for MW, CLL, MZL or FL 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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®)
Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
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®)
Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
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®)
Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
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®)
Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
Obinutuzumab
according to the Summary of Product Characteristics (SmPC).
Interventions
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Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
Obinutuzumab
according to the Summary of Product Characteristics (SmPC).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in an interventional clinical trial during zanubrutinib treatment.
18 Years
ALL
No
Sponsors
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BeOne Medicines I GmbH Switzerland
UNKNOWN
iOMEDICO AG
INDUSTRY
Responsible Party
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Principal Investigators
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Jens Kisro, Dr.
Role: PRINCIPAL_INVESTIGATOR
Lübecker Onkologische Schwerpunktpraxis
Richard Greil, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Salzburg, Klinik für Innere Medizin III
Locations
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Universitätsklinikum Salzburg, Klinik für Innere Medizin III
Salzburg, , Austria
Lübecker Onkologische Schwerpunktpraxis
Lübeck, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IOM-100461
Identifier Type: -
Identifier Source: org_study_id
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