Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

• Status: Recruiting
• Trial end date: 2022-07-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Zanubrutinib

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

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.