RecruitingChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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).
Sponsor: Dana-Farber Cancer Institute
You may qualify if…
- ✓ 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 BTK inhibitor or a BCL-2 inhibitor, but not both, and must not have experienced disease progression as defined by iwCLL criteria while receiving therapy.
- ✓ For enrollment to Cohort C: participants must have a disease that progressed during therapy with a covalent BTK inhibitor, not including zanubrutinib.
- ✓ Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of zanubrutinib and venetoclax in participants \< 18 years of age and CLL/SLL is extremely rare in this population, children are excluded from this study.
- ✓ ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A).
- ✓ Participants must have adequate organ function as defined below:
You may not qualify if…
- ✕ Known BTK C481X mutation.
- ✕ For enrollment to Cohort B: participants who have received prior treatment with both a BTK inhibitor and BCL-2 inhibitor.
- ✕ Participants who have had previous anti-cancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy, surgery, investigational agents, and/or tumor embolization) within 2 weeks of Cycle 1 Day 1 with the following exceptions:
- ✕ Hormonal therapy given in the adjuvant setting
- ✕ Corticosteroid therapy (prednisone or equivalent ≤ 20 mg daily) is allowed as clinically warranted as long as the dose is stabilized at least for 7 days prior to initial dosing. Topical, inhaled, intra-articular, or ophthalmologic corticosteroids are permitted
- ✕ Participants enrolling to Cohort C may remain on prior BTK inhibitor therapy up until 2 days prior to Cycle 1 Day 1
- ✕ History of a prior allogeneic hematologic stem cell transplant.
- ✕ Participants with known central nervous system (CNS) involvement, because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with no known history of CNS involvement are not required to undergo CT scan or lumbar puncture (LP) for trial eligibility unless the participant is symptomatic as judged by the treating investigator.
Where it's recruiting
Maine
Scarborough
Massachusetts
Boston · South Weymouth
Source: ClinicalTrials.gov · NCT05168930 · last updated 2025-12-05