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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
955
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.
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.
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Carti Cancer Center
Little Rock, Arkansas, United States
Rocky Mountain Cancer Centers Centennial
Centennial, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Florida Cancer Specialists Fort Myers
Fort Myers, Florida, United States
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
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
Time frame: Up to 5 years
Duration of Response (DOR)
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.
Time frame: Up to 5 years
Overall Survival (OS)
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
Time frame: Up to 5 years
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Scri Florida Cancer Specialists North
St. Petersburg, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Forrest General Hospital Cancer Center
Hattiesburg, Mississippi, United States
...and 143 more locations