A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
- Conditions
- Mature B-Cell Malignancies
- Registration Number
- JPRN-jRCT2080224959
- Lead Sponsor
- BeiGene, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 62
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 Waldenstrom'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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method