Actively Recruiting
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Led by Dana-Farber Cancer Institute · Updated on 2025-12-05
45
Participants Needed
4
Research Sites
349 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as per 2018 International Workshop on CLL criteria
- Relapsed after at least one prior therapy and currently require treatment
- For Cohort A: No prior treatment with covalent BTK or BCL-2 inhibitors
- For Cohort B: Prior treatment with either BTK or BCL-2 inhibitor, but not both, and no disease progression during therapy
- For Cohort C: Disease progressed during therapy with a covalent BTK inhibitor (not zanubrutinib)
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score 60% or higher)
- Adequate organ function including platelets ≥ 20,000/mcL, bilirubin ≤ 2 times upper limit of normal unless due to specific causes, AST and ALT ≤ 4 times upper limit of normal, and creatinine clearance ≥ 50 mL/min
- Agreement to use effective contraception during study participation and for 4 months after treatment
- Ability to understand and sign informed consent
- Ability to swallow and retain oral medication
You will not qualify if you...
- Known BTK C481X mutation
- For Cohort B: Prior treatment with both BTK and BCL-2 inhibitors
- Anti-cancer therapy within 2 weeks before starting study treatment, except certain hormonal or corticosteroid therapies
- History of allogeneic hematologic stem cell transplant
- Known central nervous system involvement
- Receiving other investigational agents at study entry
- History of other malignancies unless treated and disease-free for 2 years or low-risk cancers as specified
- Vaccination with live attenuated vaccines within 4 weeks before starting study treatment
- Recent or uncontrolled infections
- Known bleeding disorders
- History of stroke, intracranial hemorrhage, or major bleeding within 6 months
- Requirement for warfarin or vitamin K antagonists for anticoagulation
- Known use of moderate or strong CYP3A inhibitors or inducers
- Known HIV, active hepatitis B or C infection
- Allergic reactions to compounds similar to zanubrutinib or venetoclax
- Psychiatric or social situations limiting compliance
- Pregnant or breastfeeding women
- Malabsorption syndrome or significant gastrointestinal disease
- Active significant cardiovascular disease
- Any life-threatening illness or condition that could compromise safety or study integrity
- Active autoimmune anemia or thrombocytopenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
New England Cancer Specialists
Scarborough, Maine, United States, 04074
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
Actively Recruiting
Research Team
D
DFCI Clinical Trials Hotline
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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