Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
- Registration Number
- NCT04172246
- Lead Sponsor
- BeiGene
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 55
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib Zanubrutinib -
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment 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 Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) 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 Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) 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 Part 2: Overall response rate as assessed by Independent Review Committee (IRC) 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 occurs first Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib Up to 29 days Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib Up to 29 days
- Secondary Outcome Measures
Name Time Method Part 1: Progression-free survival (PFS) as assessed by the investigator 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 Part 1: Duration of response as assessed by the investigator 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 Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) 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 Part 1: Overall response rate (ORR) as assessed by the investigator 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 Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC 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 Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells Predose up to 24 hours postdose Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC 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 Part 2: Progression-free survival (PFS) as assessed by IRC 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 Part 2: Duration of response as assessed by IRC 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 To assess the efficacy of zanubrutinib as measured by overall survival Overall survival defined as time from start of study treatment to death due to any cause Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC 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 Part 2: Major response rate (partial response or better) for WM as assessed by IRC 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 Part 2: Rate of partial response or better for CLL as assessed by IRC 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 Part 2: Overall response rate (ORR) by disease type as assessed by the investigator 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 Part 1: Time to response as assessed by the investigator 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 Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) 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 Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1) Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC 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 Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment 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 Part 2: Time to response as assessed by IRC 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
Trial Locations
- Locations (15)
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashishi, Aichi, Japan
Chiba Cancer Center
🇯🇵Chibashi, Chiba, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyamashi, Ehime, Japan
Kurume University Hospital
🇯🇵KurumeShi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵SapporoShi, Hokkaido, Japan
Aiiku Hospital
🇯🇵SapporoShi, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵KobeShi, Hyogo, Japan
Kanagawa Cancer Center
🇯🇵Yokohamashi, 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
🇯🇵YokohamaShi, Japan