Clinical trial · Interventional
Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
NCT04172246CI-TRIAL-00097703completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mature B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanubrutinib
- interventionNames
- Drug: Zanubrutinib
Primary outcomes (6)
- measure
- Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
- timeFrame
- Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
- measure
- Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
- timeFrame
- Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier
- measure
- Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.