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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04170283
Ethics application status
Date submitted
18/11/2019
Date registered
20/11/2019
Date last updated
23/10/2024

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)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden - Canberra
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [10] 0 0
Brisbane Clinic For Lymphoma - Greenslopes
Recruitment hospital [11] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Flinders Medical Centre - Bedford PK
Recruitment hospital [14] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [15] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [16] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [17] 0 0
Monash Health - Clayton
Recruitment hospital [18] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [19] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [20] 0 0
Barwon Health the Geelong Hospital - Geelong
Recruitment hospital [21] 0 0
Austin Health - Heidelberg
Recruitment hospital [22] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [23] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [24] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [25] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [26] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2640 - East Albury
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower
Recruitment postcode(s) [9] 0 0
4102 - Brisbane
Recruitment postcode(s) [10] 0 0
4120 - Greenslopes
Recruitment postcode(s) [11] 0 0
4224 - Tugun
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
5042 - Bedford PK
Recruitment postcode(s) [14] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [15] 0 0
7000 - Hobart
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3065 - Fitzroy
Recruitment postcode(s) [19] 0 0
3199 - Frankston
Recruitment postcode(s) [20] 0 0
3220 - Geelong
Recruitment postcode(s) [21] 0 0
3084 - Heidelberg
Recruitment postcode(s) [22] 0 0
3144 - Malvern
Recruitment postcode(s) [23] 0 0
3000 - Melbourne
Recruitment postcode(s) [24] 0 0
3004 - Melbourne
Recruitment postcode(s) [25] 0 0
6009 - Nedlands
Recruitment postcode(s) [26] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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United States of America
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Colorado
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Jiangsu
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China
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Jilin
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China
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Liaoning
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Czechia
State/province [32] 0 0
Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Prague
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Czechia
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Praha
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France
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Bordeaux
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France
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La Roche sur Yon
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France
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Le Mans
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France
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Paris
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France
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Tours
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Germany
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Sigmaringen
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Greece
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Athens
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Bologna
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Meldola
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Milano
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Modena
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Novara
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Ravenna
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Roma
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Terni
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Torino
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Udine
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Korea, Republic of
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Busan Gwang'yeogsi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul Teugbyeolsi
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Amsterdam
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Auckland
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Christchurch
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Hamilton Waikato
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Takapuna
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Tauranga
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Wellington
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Bialystok
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Brzozow
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Chorzow
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Gdansk
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Gdask
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Krakow
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Lodz
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Skorzewo Poznan
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Barcelona
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Girona
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Toledo
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Sweden
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Lund
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Sweden
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Stockholm
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Turkey
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Tekirdag
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United Kingdom
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Aberdeen
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Birmingham
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United Kingdom
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Bournemouth
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United Kingdom
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Canterbury
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United Kingdom
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Glasgow
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United Kingdom
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Greater Manchester
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Headington
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United Kingdom
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Leeds
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London
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United Kingdom
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Nottingham
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Plymouth
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United Kingdom
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Southampton

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/study/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/study/NCT04170283