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New targeted pill shows promise for japanese blood cancer patients

NCT ID NCT04172246

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a drug called zanubrutinib in 55 Japanese patients with B-cell blood cancers that had come back or not responded to prior treatment. The goal was to check safety and how well the drug works. Zanubrutinib is taken as a pill twice daily and targets a protein that helps cancer cells grow.

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 taken as a pill)
What this could lead to
If successful, zanubrutinib could offer a new treatment option for Japanese patients with certain B-cell blood cancers.
What could go wrong
This is an early-phase study with a small number of participants (55). Results may not apply to all patients, and side effects are possible.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

55 people

The number who actually took part.

Started

Jan 2020

Finished

Jun 2025

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.

Ages

20 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.

Key Inclusion Criteria: * Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenström's macroglobulinemia * Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy * Meeting at least one of criteria for requiring treatment * Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level \> 0.5 g/dL for WM participants * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 * Life expectancy of \> 4 months Key Exclusion Criteria: * Known central nervous system involvement by lymphoma/leukemia * Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome * Prior allogeneic stem cell transplant * Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib * Active fungal, bacterial, and/or viral infection requiring systemic therapy * Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199) * Pregnant, lactating, or nursing women * Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma neoplasm of mature B-cells Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Mature B-cell malignancies

Contacts and locations

Locations

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804, Japan

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553, Japan

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717, Japan

  • Gifu Municipal Hospital

    Gifu, 500-8513, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kobe City Medical Center General Hospital

    KobeShi, Hyōgo, 650-0047, Japan

  • Kurume University Hospital

    KurumeShi, Fukuoka, 830-0011, Japan

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital

    ChuoKu, Tokyo, 104-0045, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511, Japan

  • Toyohashi Municipal Hospital

    Toyohashishi, Aichi-ken, 441-8570, Japan

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855, Japan

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