Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

Launched by BEIGENE · Nov 19, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called zanubrutinib for Japanese patients with certain types of blood cancers known as mature B-cell malignancies. These include conditions like chronic lymphocytic leukemia and mantle cell lymphoma, among others. The goal of the study is to explore how effective zanubrutinib is in treating these cancers, especially in patients whose disease has not responded to previous treatments or has come back after treatment.

To participate in this trial, patients need to have a confirmed diagnosis of one of the specified B-cell malignancies and must have measurable disease that requires treatment. They should also be in relatively good health, with a life expectancy of at least four months. Participants will receive zanubrutinib and be closely monitored for its effects. It’s important to note that the study is currently active but not recruiting new participants, which means no new patients can join at this time. If you have further questions or think you may qualify in the future, it’s a good idea to talk to your healthcare provider about your options.

Gender

ALL

Eligibility 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.