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Mature B-cell MalignanciesPhase 1/2NCT04172246

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

A Phase 1/2 study testing Zanubrutinib in people with Mature B-cell Malignancies, run by BeiGene at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies. This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Mature B-cell Malignancies
What is being tested?
Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
15 sitesJapan
Study dates
29 Jan 2020to 30 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    ChuoKu, Tokyo, 104-0045

  • Gifu Municipal Hospital

    Gifu, 500-8513

  • Kobe City Medical Center General Hospital

    KobeShi, Hyōgo, 650-0047

  • Kurume University Hospital

    KurumeShi, Fukuoka, 830-0011

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Aiiku Hospital

    Sapporo, Hokkaido, 064-0804

  • Toyohashi Municipal Hospital

    Toyohashishi, Aichi-ken, 441-8570

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855

Other trials in Japan

About this study

Official title: A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies

This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies.

This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.

Being tested
Zanubrutinib
Keywords
relapsed/refractory chronic lymphocytic leukemia, relapsed/refractory small lymphocytic lymphoma, treatment-naïve chronic lymphocytic leukemia, treatment-naïve /small lymphocytic lymphoma, relapsed/refractory mantle cell lymphoma, relapsed/refractory marginal zone lymphoma, relapsed/refractory follicular lymphoma, relapsed/refractory Waldenström macroglobulinemia, treatment-naïve Waldenström macroglobulinemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111

    Zanubrutinib at 160 mg orally twice daily

Study groups in NCT04172246
Study groupRoleWhat they receive
ZanubrutinibExperimentalNot described
Receives: Drug: Zanubrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  2. Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  3. Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  4. Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib

    Measured: Up to 29 days

  5. Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib

    Measured: Up to 29 days

  6. Part 2: Overall response rate as assessed by Independent Review Committee (IRC)

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever occurs first

Secondary outcomes (20)

  1. Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells

    Measured: Predose up to 24 hours postdose

  2. Part 1: Overall response rate (ORR) as assessed by the investigator

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  3. Part 1: Progression-free survival (PFS) as assessed by the investigator

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  4. Part 1: Duration of response as assessed by the investigator

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  5. Part 1: Time to response as assessed by the investigator

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  6. Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  7. Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  8. Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib

    Measured: Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1)

  9. Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  10. Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  11. Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  12. Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  13. Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  14. Part 2: Major response rate (partial response or better) for WM as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  15. Part 2: Rate of partial response or better for CLL as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  16. Part 2: Overall response rate (ORR) by disease type as assessed by the investigator

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  17. Part 2: Progression-free survival (PFS) as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  18. Part 2: Duration of response as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  19. Part 2: Time to response as assessed by IRC

    Measured: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

  20. To assess the efficacy of zanubrutinib as measured by overall survival

    Measured: Overall survival defined as time from start of study treatment to death due to any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start29 Jan 2020
  3. Primary completion10 May 2023
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172246
Sponsor's protocol ID
BGB-3111-111
Other IDs
JapicCTI-195047
Status last verified
Jul 2025
First submitted
14 Nov 2019
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Zanubrutinib in people with Mature B-cell Malignancies, run by BeiGene at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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