Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

Last updated: September 30, 2024
Sponsor: iOMEDICO AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Lymphoma, B-cell

Leukemia

Treatment

Obinutuzumab

Zanubrutinib

Clinical Study ID

NCT05326308
IOM-100461
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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-basedprevious 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

Exclusion Criteria:

  • Contraindications according to SmPC for patients with WM, CLL, MZL or FL

  • Participation in an interventional clinical trial during zanubrutinib treatment.

Study Design

Total Participants: 605
Treatment Group(s): 2
Primary Treatment: Obinutuzumab
Phase:
Study Start date:
April 26, 2022
Estimated Completion Date:
August 31, 2028

Study Description

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.

Connect with a study center

  • Universitätsklinikum Salzburg, Klinik für Innere Medizin III

    Salzburg, A-5020
    Austria

    Active - Recruiting

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, Schleswig-Holstein D-23562
    Germany

    Active - Recruiting

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