Zanubrutinib in Patients With Waldenström’s Macroglobulinemia (ARIADNE)

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

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