Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

  • STATUS
    Recruiting
  • End date
    Jul 6, 2022
  • participants needed
    53
  • sponsor
    BeiGene
Updated on 1 March 2021
Investigator
Eric Hedrick, MD
Primary Contact
Kurume University Hospital (0.6 mi away) Contact
+14 other location

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.

Details
Condition Mature B-cell Malignancies, Mature B-cell Malignancies, Mature B-cell Malignancies
Treatment Zanubrutinib
Clinical Study IdentifierNCT04172246
SponsorBeiGene
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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