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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

705 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-26

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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ARIADNE will collect and analyze data of adult patients with WM, CLL, MZL or FL 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, 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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Waldenström's Macroglobulinemia Chronic Lymphocytic Leukemia Marginal Zone Lymphoma Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

according to the Summary of Product Characteristics (SmPC).

Obinutuzumab

Intervention Type DRUG

according to the Summary of Product Characteristics (SmPC).

Interventions

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Zanubrutinib

according to the Summary of Product Characteristics (SmPC).

Intervention Type DRUG

Obinutuzumab

according to the Summary of Product Characteristics (SmPC).

Intervention Type DRUG

Other Intervention Names

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Brukinsa® Gazyvaro®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeOne Medicines I GmbH Switzerland

UNKNOWN

Sponsor Role collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Lübecker Onkologische Schwerpunktpraxis

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Daniel Kummer, Dr.

Role: CONTACT

+49761152420

Facility Contacts

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Richard Greil, Prof.

Role: primary

+435725525800

Jens Kisro, Dr.

Role: primary

+4945170797226

Other Identifiers

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IOM-100461

Identifier Type: -

Identifier Source: org_study_id

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