NCT05168930

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Venetoclax	C4-15
DRUG	Zanubrutinib	C1-15

Timeline

• Start date: 2022-02-18
• Primary completion: 2026-10-28
• Completion: 2028-10-28
• First posted: 2021-12-23
• Last updated: 2025-12-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study