Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Mature B-cell Malignancies
Age (in years)
20+
Phase
Phase 1/Phase 2
Participants needed
53
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04172246
Study number
BGB-3111-111
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