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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-195047 | Registry Identifier | Jape |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib at 160 mg orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Toyohashi Municipal Hospital |
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.
See plan description
See plan description
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
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| 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 |
| Part 2: 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 2: 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 2: Maximum Plasma Concentration (Cmax) of zanubrutinib | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Overall survival defined as time from start of study treatment to death due to any cause |
| 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 |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |