NCT04172246CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 14 Nov 2019
- Start date
- 29 Jan 2020
- Primary completion date
- 10 May 2023
- Lead sponsor
- BeiGene
- NCT number
- NCT04172246
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 55
- From 29 Jan 2020 to the primary completion date, 10 May 2023
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic stem cell transplant
- Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
- 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)
Other illness
- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Other
- Known central nervous system involvement by lymphoma/leukemia
- Pregnant, lactating, or nursing women
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aomori Prefectural Central Hospital Coordinator of this site? Confirm its status | Aomori | Japan | Unknown status |
| Chiba Cancer Center Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Gifu Municipal Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | KobeShi | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | KurumeShi | Japan | Unknown status |
| Matsuyama Red Cross Hospital Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| The Japanese Red Cross Nagasaki Genbaku Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| National Hospital Organization Hokkaido Cancer Center Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Aiiku Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Toyohashi Municipal Hospital Coordinator of this site? Confirm its status | Toyohashishi | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Yokohama Municipal Citizens Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.