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Zanubrutinib and Venetoclax in CLL (ZANU-VEN) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

A Phase 2 Trial of Zanubrutinib and Venetoclax in Previously Treated CLL/SLL Patients

NCT05168930•Dana-Farber Cancer Institute

Summary

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).

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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:
•* Platelet count ≥ 20,000/mcL
•* Total bilirubin ≤ 2 × institutional upper limit of normal (ULN) (unless due to controlled hemolysis, Gilbert's disease, or is of non-hepatic origin)
•* AST (SGOT) and ALT (SGPT) ≤ 4 × institutional ULN
•* Serum Creatinine ≤ 1.5 × institutional ULN, OR
•* Calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault formula)
+31 more criteria

Locations (4)

New England Cancer Specialists

Scarborough, Maine, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

South Shore Hospital

South Weymouth, Massachusetts, United States

Key Dates

Start Date

February 18, 2022

Primary Completion Date

October 28, 2026

Completion Date

October 28, 2028

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

Interventions

Venetoclax

DRUG

Zanubrutinib

DRUG

Contacts

DFCI Clinical Trials Hotline

CONTACT

877-DF-TRIAL DFCILymphomaResearchNurses@partners.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

Inclusion Criteria

Exclusion Criteria

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