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New study tracks targeted drug zanubrutinib in rare blood cancer

NCT ID NCT05640102

Disease control Sponsor: BeiGene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study is tracking how well the drug zanubrutinib works and its safety in people with Waldenström macroglobulinemia, a rare blood cancer. Researchers are especially interested in patients with specific genetic mutations and those from racial and ethnic minority groups. The study will collect information from medical records and follow participants over time to see how they respond to treatment.

What this could mean

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

Active substance
zanubrutinib (a targeted cancer drug, also called Brukinsa)
What this could lead to
If successful, this study could confirm that zanubrutinib is effective and safe for a broader range of patients with Waldenström macroglobulinemia, including those from racial and ethnic minority groups.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also relatively small (111 participants) and focuses on a rare blood cancer, so findings may not apply to everyone.

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 111 people

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

Started

Mar 2023

Expected to finish

Dec 2027

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 participants with WM who are either already receiving or are planned to start treatment with zanubrutinib

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: * Clinical and definitive histologic diagnosis of WM * Measurable disease, as defined by a serum immunoglobulin M (IgM) level \> 0.5 g/dL at the time of zanubrutinib initiation * Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM * Bone marrow specimens with central MYD88 test results of: 1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT Exclusion Criteria: * Evidence of disease transformation before the first dose of zanubrutinib * Evidence of other non-Hodgkin Lymphoma (NHL) subtypes * Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results * Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

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Conditions

The condition(s) this trial relates to.

Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Waldenstrom macroglobulinemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-3012, United States

  • Clearview Cancer Institute

    RECRUITING

    Huntsville, Alabama, 35805-2606, United States

  • Comprehensive Cancer Centers of Nevada

    RECRUITING

    Las Vegas, Nevada, 89169-3321, United States

  • Eisenhower Medical Center, Lucy Curci Cancer Center

    RECRUITING

    Rancho Mirage, California, 92270-3221, United States

  • Hattiesburg Hematology and Oncology Clinic

    ACTIVE_NOT_RECRUITING

    Hattiesburg, Mississippi, 39401-7233, United States

  • Los Angeles Cancer Network (Lacn)

    RECRUITING

    Glendale, California, 91204-3640, United States

  • Pan American Oncology Trials, Llc

    ACTIVE_NOT_RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • South Alabama Medical Science Foundation Mitchell Cancer Institute

    RECRUITING

    Mobile, Alabama, 36604-1405, United States

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Other studies related to the condition(s) this trial covers.