For Healthcare Professionals

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:


  1. 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
  2. Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
  3. Meeting at least one of criteria for requiring treatment
  4. 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
  5. Eastern Cooperative Oncology Group performance status of 0, 1, or 2
  6. Life expectancy of > 4 months

EXCLUSION CRITERIA

Key Exclusion Criteria:


  1. Known central nervous system involvement by lymphoma/leukemia
  2. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
  3. Prior allogeneic stem cell transplant
  4. Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
  5. Active fungal, bacterial, and/or viral infection requiring systemic therapy
  6. 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)
  7. Pregnant, lactating, or nursing women
  8. 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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Mature B-cell Malignancies

Age (in years)

20+

Phase

Phase 1/Phase 2

Participants needed

53

Est. Completion Date

Sep 30, 2024

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT04172246

Study number

BGB-3111-111

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