ClinicalTrials.gov record NCT05326308

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationAustria, Germany
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a non-interventional, prospective study collecting data from adults with WM, CLL, MZL or FL who are being treated with zanubrutinib (Brukinsa®) as decided by their physician. The study will track medical resource use, safety, treatment outcomes, biomarkers and patient-reported quality of life over time. It includes separate cohorts for each disease and follows patients during treatment and follow-up (up to about 6.3 years). The study particularly aims to gather data in patients previously treated with BTK inhibitors, older patients, and those with comorbidities.

What it is studying. The study is measuring how zanubrutinib is used in routine care and gathering real-world information on its safety, tolerability, effectiveness, effects on quality of life, treatment satisfaction, biomarkers, and healthcare use (for example hospital visits and emergency visits).

What the researchers hope to learn. To describe medical resource utilization during zanubrutinib treatment; to assess real-world effectiveness, safety and tolerability; to collect treatment satisfaction and health-related quality-of-life data; and to explore biomarkers related to treatment.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Zanubrutinib
  • Obinutuzumab

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants continue zanubrutinib (and obinutuzumab for FL) as prescribed by their doctor; the study does not assign treatment. Study staff will collect data from routine care and follow participants during treatment and for up to 6.3 years, including hospitalizations, emergency visits, adverse events, blood-test results (for example neutropenia and IgM levels in WM), treatment doses and changes, transfusions, antibiotic use, and later anti-cancer therapies. Participants will complete quality-of-life questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and may have biomarker information recorded from routine tests.

How the study is structured. A prospective observational cohort (non-interventional) study. Patients start zanubrutinib according to routine care before joining; the study records clinical data, adverse events, laboratory/biomarker results, health-related quality-of-life questionnaires, and healthcare resource use during treatment and follow-up for up to about 6.3 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Austria, Germany. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 26, 2022
Primary completion
August 2028 (estimated)
Study completion
August 2028 (estimated)
Target enrollment
845 participants (estimated)
Last updated on registry
Sep 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
iOMEDICO AG
Collaborators
  • BeOne Medicines I GmbH

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
interventional
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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