Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

BeiGene

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mature B-cell Malignancies

Treatments: Drug: Zanubrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04172246

JapicCTI-195047 (Registry Identifier)

BGB-3111-111

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Zanubrutinib

Experimental group

Treatment:

Drug: Zanubrutinib