Description:
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.
Title
- Brief Title: Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
- Official Title: A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
Clinical Trial IDs
- ORG STUDY ID:
BGB-3111-111
- SECONDARY ID:
JapicCTI-195047
- NCT ID:
NCT04172246
Conditions
- Mature B-cell Malignancies
Interventions
| Drug | Synonyms | Arms |
|---|
| Zanubrutinib | BGB-3111 | Zanubrutinib |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Zanubrutinib | Experimental | | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells |
| Time Frame: | Predose up to 24 hours postdose |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Overall response rate (ORR) as assessed by the investigator |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Progression-free survival (PFS) as assessed by the investigator |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Duration of response as assessed by the investigator |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 1: Time to response as assessed by the investigator |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib |
| Time Frame: | Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1) |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Major response rate (partial response or better) for WM as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Rate of partial response or better for CLL as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Overall response rate (ORR) by disease type as assessed by the investigator |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Progression-free survival (PFS) as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Duration of response as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Part 2: Time to response as assessed by IRC |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | To assess the efficacy of zanubrutinib as measured by overall survival |
| Time Frame: | Overall survival defined as time from start of study treatment to death due to any cause |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | BeiGene |
Trial Keywords
- relapsed/refractory chronic lymphocytic leukemia
- relapsed/refractory small lymphocytic lymphoma
- treatment-naïve chronic lymphocytic leukemia
- treatment-naïve /small lymphocytic lymphoma
- relapsed/refractory mantle cell lymphoma
- relapsed/refractory marginal zone lymphoma
- relapsed/refractory follicular lymphoma
- relapsed/refractory Waldenström macroglobulinemia
- treatment-naïve Waldenström macroglobulinemia
Last Updated
February 21, 2021
