B-cell Malignancies
Conditions
Keywords
Zanubrutinib, Bruton's tyrosine kinase (BTK) inhibitor, long-term extension
Brief summary
The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up after treatment. Information collected in this study will help health authorities better understand the long-term effects of zanubrutinib.
Interventions
DRUGZanubrutinib
Participants will receive a total dose of 320 mg daily, given either as 160 mg BID or 320 mg QD, or the last dose level received in the sponsor parent study.
DRUGTislelizumab
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.
Sponsors
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Currently participating or participated recently in a BeOne (previously 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 BeOne (previously 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
Exclusion criteria
1. Permanently discontinued from zanubrutinib treatment in the BeOne (previously 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 5 years | Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) and according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 5 years | PFS is defined as time from start of treatment in an eligible BeOne (previously BeiGene) study to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment |
| Duration of Response (DOR) | Up to 5 years | DOR is defined as the time from the date that a confirmed response (CR or PR) was first observed in an eligible BeOne (previously BeiGene) study to the date of first documented disease progression or death, whichever occurred first, and as determined by the investigator. |
| Overall Survival (OS) | Up to 5 years | OS is defined as the ime from the starting date of zanubrutinib in the eligible BeOne (previously BeiGene) study to the date of death due to any reason |
Countries
Australia, China, Czechia, France, Germany, Greece, Italy, Japan, Netherlands, New Zealand, Poland, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed