Dana-Farber Cancer Institute
This study is being done to test the effectiveness of zanubrutinib in combination with venetoclax in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This is an open-label, non-randomized phase 2 trial assessing the combination of zanubrutinib and venetoclax in adult participants with CLL or SLL who have relapsed after at least one prior therapy. Participants will receive study treatment for 15 months initially. There is an option for an additional 12 months of re-treatment with study therapy at the time of disease recurrence. Participants will be followed for 36 months after they discontinue the study drugs. The study will enroll up to 45 participants. BeiGene Ltd. is providing funding for the trial and the study drug zanubrutinib.
Inclusion Criteria * Confirmed diagnosis of CLL or SLL as per 2018 International Workshop on CLL (IWCLL) criteria. * Participants must have relapsed after at least one prior line of therapy and must currently require therapy by 2019 IWCLL criteria. * For enrollment to Cohort A: Participants must be covalent BTK and BCL-2 inhibitor naïve. Participants who have received prior therapy with a covalent BTK or BCL-2 inhibitor are not eligible, including but not limited to prior treatment with ibrutinib or acalabrutinib. * For enrollment to Cohort B: Participants must have had prior treatment with a…
C4-15
C1-15
Arctuva estimate
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