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.
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
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)
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- 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
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.
- Conditions
- Mature B-cell Malignancies
- 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 group | Role | What they receive |
|---|---|---|
| Zanubrutinib | Experimental | Not described Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib
Measured: Up to 29 days
Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib
Measured: Up to 29 days
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)
Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells
Measured: Predose up to 24 hours postdose
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted21 Nov 2019
- Study start29 Jan 2020
- Primary completion10 May 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
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.