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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04170283




Registration number
NCT04170283
Ethics application status
Date submitted
18/11/2019
Date registered
20/11/2019
Date last updated
27/10/2023

Titles & IDs
Public title
Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
Scientific title
An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies
Secondary ID [1] 0 0
BGB-3111-LTE1
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Zanubrutinib (BGB-3111) - All participants to receive open-label zanubrutinib

Experimental: Zanubrutinib in combination with Tislelizumab - Participants to receive the combination as in the parent study (Australia Only)


Treatment: Drugs: Zanubrutinib
Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study.

Treatment: Drugs: Tislelizumab
Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks..
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) per investigator assessment
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Duration of Response (DOR) per investigator assessment
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
1. Currently participating or participated recently in a BeiGene parent study

2. Intent to continue or start zanubrutinib treatment after any of the following:

1. At time of final analysis or study closure of the eligible BeiGene parent study

2. At time of progressive disease (PD); and investigator, patient and medical
monitor agree it is in the patient's best interest

3. At an alternative timepoint for an alternative reason

3. Patient who is currently on zanubrutinib treatment:

Does not meet any protocol-specified criteria for zanubrutinib hold or permanent
discontinuation, and, in the opinion of the investigator, will continue to benefit
from zanubrutinib treatment

4. Zanubrutinib-naive patient:

Must meet the following criteria = 15 days before first dose of study drug:

1. Platelets = 50,000/mm3

2. Absolute neutrophil count = 750/mm3

3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 x upper
limit of normal

4. Serum total bilirubin = 3 x upper limit of normal (not required for Gilbert
Syndrome)

5. QT interval corrected for heart rate using Fridericia's formula (QTcF) = 480 msec

6. No known New York Heart Association (NYHA) Class III or IV congestive heart
failure

7. Creatinine clearance = 30 mL/min

5. Female participants of childbearing potential and nonsterile males must be willing to
use a highly effective method of birth control.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due
to unacceptable toxicity, non-compliance with study procedures, or withdrawal of
consent

2. Uncontrolled active systemic infection or recent infection requiring parenteral
anti-microbial therapy

3. Life-threatening illness, medical condition or organ system dysfunction which, in the
investigator's opinion, could compromise the participant's safety, interfere with the
absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk

4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based
therapies, or any prohibited concomitant therapy outlined in the protocol

5. Pregnant or lactating woman

6. Inability to comply with study procedures

7. Concurrent participation in another therapeutic clinical study

8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding
zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Fujian
Country [8] 0 0
China
State/province [8] 0 0
Guangdong
Country [9] 0 0
China
State/province [9] 0 0
Heilongjiang
Country [10] 0 0
China
State/province [10] 0 0
Henan
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jilin
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Sichuan
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Kralove
Country [19] 0 0
Czechia
State/province [19] 0 0
Ostrava
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha
Country [22] 0 0
Germany
State/province [22] 0 0
Sigmaringen
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Italy
State/province [24] 0 0
Bologna
Country [25] 0 0
Italy
State/province [25] 0 0
Meldola
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Modena
Country [28] 0 0
Italy
State/province [28] 0 0
Novara
Country [29] 0 0
Italy
State/province [29] 0 0
Ravenna
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Italy
State/province [31] 0 0
Terni
Country [32] 0 0
Italy
State/province [32] 0 0
Torino
Country [33] 0 0
Italy
State/province [33] 0 0
Udine
Country [34] 0 0
Netherlands
State/province [34] 0 0
Amsterdam
Country [35] 0 0
Netherlands
State/province [35] 0 0
Utrecht
Country [36] 0 0
New Zealand
State/province [36] 0 0
Takapuna
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Chorzow
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Salamanca
Country [42] 0 0
Spain
State/province [42] 0 0
Valencia
Country [43] 0 0
Sweden
State/province [43] 0 0
Stockholm
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Bournemouth
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Glasgow
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Greater Manchester
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Headington
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leeds
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Nottingham
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in
participants with B-cell malignancies who participated in a BeiGene parent study for
zanubrutinib.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04170283
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04170283