Evaluating zanubrutinib treatment in patients with certain blood cancers
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
This study is trying to see how well zanubrutinib works and how it affects the lives of adults with certain blood cancers like Waldenström's Macroglobulinemia and Chronic Lymphocytic Leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 705 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Drugs / interventions | obinutuzumab, zanubrutinib |
| Locations | 2 sites (Salzburg and 1 other locations) |
| Trial ID | NCT05326308 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather and analyze real-world data on adult patients with Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, and Follicular Lymphoma who are receiving treatment with zanubrutinib. The study will assess medical resource utilization, treatment effectiveness, safety, tolerability, and patient satisfaction, along with health-related quality of life. By focusing on patients with various treatment histories and comorbidities, the study seeks to fill gaps in existing data regarding this treatment option.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, or Follicular Lymphoma who are in need of treatment.
Not a fit: Patients who are contraindicated for zanubrutinib treatment or are currently participating in an interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and quality of life improvements associated with zanubrutinib treatment for patients with these blood cancers.
How similar studies have performed: Other studies have shown promise in evaluating real-world data for similar treatments, but this specific approach with zanubrutinib in these patient populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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) * 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.
Where this trial is running
Salzburg and 1 other locations
- Universitätsklinikum Salzburg, Klinik für Innere Medizin III — Salzburg, Austria (Recruiting)
- Lübecker Onkologische Schwerpunktpraxis — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Jens Kisro, Dr. — Lübecker Onkologische Schwerpunktpraxis
- Study coordinator: Daniel Kummer, Dr.
- Email: ariadne@iomedico.com
- Phone: +49761152420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.