Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
- Conditions
- B-cell Malignancies
- Interventions
- Registration Number
- NCT04170283
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 955
Not provided
- Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
- Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
- 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
- Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
- Pregnant or lactating woman
- Inability to comply with study procedures
- Concurrent participation in another therapeutic clinical study
- History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zanubrutinib in combination with Tislelizumab Tislelizumab Participants to receive the combination as in the parent study (Australia Only) Zanubrutinib (BGB-3111) Zanubrutinib All participants to receive open-label zanubrutinib Zanubrutinib in combination with Tislelizumab Zanubrutinib Participants to receive the combination as in the parent study (Australia Only)
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 5 years Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to 5 years Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of death due to any reason
Progression-Free Survival (PFS) per investigator assessment Up to 5 years Time from the starting date of zanubrutinib in the eligible BeiGene study to the date of first documentation of disease progression or death, whichever occurs first
Duration of Response (DOR) per investigator assessment Up to 5 years Time from the date that response criteria are first met after the start of zanubrutinib in the eligible BeiGene study to the date that progressive disease (PD) is objectively documented or death, whichever occurs first
Trial Locations
- Locations (152)
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
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
Scroll for more (142 remaining)Banner Md Anderson Cancer Center🇺🇸Gilbert, Arizona, United States