NCT05326308 Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma
| NCT ID | NCT05326308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iOMEDICO AG |
| Condition | Waldenström's Macroglobulinemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 845 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 845 participants in total. It began in 2022-04-26 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, MZL and FL in a real-world setting.
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) * 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.
Contact & Investigator
Jens Kisro, Dr.
PRINCIPAL INVESTIGATOR
Lübecker Onkologische Schwerpunktpraxis
Frequently Asked Questions
Who can join the NCT05326308 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Waldenström's Macroglobulinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05326308 currently recruiting?
Yes, NCT05326308 is actively recruiting participants. Contact the research team at ariadne@iomedico.com for enrollment information.
Where is the NCT05326308 trial being conducted?
This trial is being conducted at Salzburg, Austria, Lübeck, Germany.
Who is sponsoring the NCT05326308 clinical trial?
NCT05326308 is sponsored by iOMEDICO AG. The principal investigator is Jens Kisro, Dr. at Lübecker Onkologische Schwerpunktpraxis. The trial plans to enroll 845 participants.