Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy

This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.

NCT Number	NCT06958705
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University Collaborators: AbbVie
Conditions	Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Enrollment	79 participants
Start Date	2025-12-01
Primary Completion	2027-12-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-11-25