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Real-World study tracks Zanubrutinib's impact on blood cancer patients

NCT ID NCT05326308

Knowledge-focused Sponsor: iOMEDICO AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study follows 705 adults with Waldenström's macroglobulinemia, chronic lymphocytic leukemia, marginal zone lymphoma, or follicular lymphoma who are taking zanubrutinib (with or without obinutuzumab). Researchers will track hospital visits, quality of life, and how well the drug works in routine medical practice. The goal is to fill gaps in real-world data for these cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanubrutinib (Brukinsa) and obinutuzumab (Gazyvaro)
What this could lead to
If successful, this study could show how well zanubrutinib works in real-world settings and help improve treatment guidelines for these blood cancers.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection or incomplete data. It won't prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 845 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with Waldenström's macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) or Follicular Lymphoma (FL) in need of treatment with decision for treatment with zanubrutinib (Brukinsa®) according to the Summary of Product Characteristics (SmPC).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia follicular lymphoma Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Follicular lymphoma Marginal zone lymphoma Waldenström's macroglobulinemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lübecker Onkologische Schwerpunktpraxis

    RECRUITING

    Lübeck, Schleswig-Holstein, D-23562, Germany

  • Universitätsklinikum Salzburg, Klinik für Innere Medizin III

    RECRUITING

    Salzburg, A-5020, Austria

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