Zanubrutinib + Tislelizumab for B-Cell Lymphoma
Recruiting in Palo Alto (17 mi)
+224 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: BeiGene
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Research Team
SD
Study Director
Principal Investigator
BeiGene
Eligibility Criteria
This trial is for people with B-cell malignancies who were in a previous BeiGene study. They should have stable vital signs, normal organ function, and agree to birth control if needed. It's not for those with severe heart failure, uncontrolled infections, or women who are pregnant or breastfeeding.Inclusion Criteria
Platelets ≥ 50,000/mm3
Absolute neutrophil count ≥ 750/mm3
I am currently being treated with zanubrutinib.
See 14 more
Exclusion Criteria
Pregnant or lactating woman
Inability to comply with study procedures
I do not have an ongoing serious infection or one that needed IV antibiotics recently.
See 5 more
Treatment Details
Interventions
- Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Trial OverviewThe trial tests long-term safety of Zanubrutinib alone or with Tislelizumab in patients previously enrolled in related studies. The focus is on those who may continue benefiting from Zanubrutinib after showing no progression of disease.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Zanubrutinib in combination with TislelizumabExperimental Treatment2 Interventions
Participants to receive the combination as in the parent study (Australia Only)
Group II: Zanubrutinib (BGB-3111)Experimental Treatment1 Intervention
All participants to receive open-label zanubrutinib
Zanubrutinib is already approved in China for the following indications:
Approved in China as Brukinsa for:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oncology and Hematology Associates of Southwest Virginia, IncRoanoke, VA
Oregon Health and Science UniversityPortland, OR
Medical Oncology AssociatesSpokane, WA
University of Michigan Health System - OncologyAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor
Trials
216
Patients Recruited
32,500+