Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
2 other identifiers
interventional
55
1 country
15
Brief 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. No formal hypothesis testing will be performed given the small sample size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2020
Longer than P75 for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
January 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedNovember 21, 2025
July 1, 2025
3.3 years
November 14, 2019
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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)
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
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
Up to 29 days
Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib
Up to 29 days
Part 2: Overall response rate as assessed by Independent Review Committee (IRC)
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
Predose up to 24 hours postdose
Part 1: Overall response rate (ORR) as assessed by the investigator
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
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
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
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 more secondary outcomes
Study Arms (1)
Zanubrutinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (15)
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Toyohashi Municipal Hospital
Toyohashishi, Aichi-ken, 441-8570, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790 8524, Japan
Kurume University Hospital
KurumeShi, Fukuoka, 830-0011, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Aiiku Hospital
Sapporo, Hokkaido, 064-0804, Japan
Kobe City Medical Center General Hospital
KobeShi, Hyōgo, 650-0047, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045, Japan
Aomori Prefectural Central Hospital
Aomori, 030-8553, Japan
Gifu Municipal Hospital
Gifu, 500-8513, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 21, 2019
Study Start
January 29, 2020
Primary Completion
May 10, 2023
Study Completion
June 30, 2025
Last Updated
November 21, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.