Trials / Recruiting
RecruitingNCT05326308
Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 705 (estimated)
- Sponsor
- iOMEDICO AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Waldenström's Macroglobulinemia
- Chronic Lymphocytic Leukemia
- Marginal Zone Lymphoma
- Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | according to the Summary of Product Characteristics (SmPC). |
| DRUG | Obinutuzumab | according to the Summary of Product Characteristics (SmPC). |
Timeline
- Start date
- 2022-04-26
- Primary completion
- 2028-08-01
- Completion
- 2028-08-01
- First posted
- 2022-04-13
- Last updated
- 2025-09-23
Locations
2 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT05326308. Inclusion in this directory is not an endorsement.