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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04172246




Registration number
NCT04172246
Ethics application status
Date submitted
14/11/2019
Date registered
21/11/2019

Titles & IDs
Public title
Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
Scientific title
A Phase 1/2 Study of Zanubrutinib in Japanese Patients With Mature B-Cell Malignancies
Secondary ID [1] 0 0
JapicCTI-195047
Secondary ID [2] 0 0
BGB-3111-111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mature B-cell Malignancies 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib

Experimental: Zanubrutinib -


Treatment: Drugs: Zanubrutinib
Zanubrutinib at 160 mg orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib
Timepoint [4] 0 0
Up to 29 days
Primary outcome [5] 0 0
Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib
Timepoint [5] 0 0
Up to 29 days
Primary outcome [6] 0 0
Part 2: Overall response rate as assessed by Independent Review Committee (IRC)
Timepoint [6] 0 0
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
Secondary outcome [1] 0 0
Part 1: Bruton tyrosine kinase (BTK) occupancy in peripheral blood mononuclear cells
Timepoint [1] 0 0
Predose up to 24 hours postdose
Secondary outcome [2] 0 0
Part 1: Overall response rate (ORR) as assessed by the investigator
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Part 1: Progression-free survival (PFS) as assessed by the investigator
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Part 1: Duration of response as assessed by the investigator
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Part 1: Time to response as assessed by the investigator
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Part 2: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Part 2: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Part 2: Maximum Plasma Concentration (Cmax) of zanubrutinib
Timepoint [8] 0 0
Predose up to 24 hours postdose Cycle 1 day 1 (C1D1) and Cycle 2 day 1 (C2D1)
Secondary outcome [9] 0 0
Part 2: Number of Participants Experiencing AEs Leading to Discontinuation of Treatment
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Part 2: Rate of complete response for chronic lymphocytic leukemia (CLL) as assessed by IRC
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Part 2: Rate of complete response with incomplete marrow for CLL as assessed by IRC
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Part 2: Rate of complete response for small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and Waldenström macroglobulinemia (WM) as assessed by IRC
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Part 2: Rate of very good partial response (VGPR) or better for WM as assessed by IRC
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
Part 2: Major response rate (partial response or better) for WM as assessed by IRC
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
Part 2: Rate of partial response or better for CLL as assessed by IRC
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Part 2: Overall response rate (ORR) by disease type as assessed by the investigator
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Part 2: Progression-free survival (PFS) as assessed by IRC
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
Part 2: Duration of response as assessed by IRC
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
Part 2: Time to response as assessed by IRC
Timepoint [19] 0 0
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
Secondary outcome [20] 0 0
To assess the efficacy of zanubrutinib as measured by overall survival
Timepoint [20] 0 0
Overall survival defined as time from start of study treatment to death due to any cause

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Aichi
Country [2] 0 0
Japan
State/province [2] 0 0
Ehime
Country [3] 0 0
Japan
State/province [3] 0 0
Fukuoka
Country [4] 0 0
Japan
State/province [4] 0 0
Hokkaido
Country [5] 0 0
Japan
State/province [5] 0 0
Hyogo
Country [6] 0 0
Japan
State/province [6] 0 0
Kanagawa
Country [7] 0 0
Japan
State/province [7] 0 0
Tokyo
Country [8] 0 0
Japan
State/province [8] 0 0
Aomori
Country [9] 0 0
Japan
State/province [9] 0 0
Chiba
Country [10] 0 0
Japan
State/province [10] 0 0
Gifu
Country [11] 0 0
Japan
State/province [11] 0 0
Nagasaki
Country [12] 0 0
Japan
State/province [12] 0 0
Okayama

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04172246