Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
NCT ID: NCT04172246
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2020-01-29
2025-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanubrutinib
Zanubrutinib
Zanubrutinib at 160 mg orally twice daily
Interventions
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Zanubrutinib
Zanubrutinib at 160 mg orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashishi, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Kurume University Hospital
KurumeShi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
KobeShi, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, Japan
Aomori Prefectural Central Hospital
Aomori, , Japan
Gifu Municipal Hospital
Gifu, , Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Yokohama Municipal Citizens Hospital
Yokohama, , Japan
Countries
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Other Identifiers
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JapicCTI-195047
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-3111-111
Identifier Type: -
Identifier Source: org_study_id
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