Last updated on February 2020

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mature B-cell Malignancies
  • Age: Between 20 - 100 Years
  • Gender: Male or Female

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 Waldenstrm'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.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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