Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment 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.
• 1\. Age: 18-80 years-old.
• 2\. Patients must have a diagnosis of CLL/SLL.
• 3\. Detectable MRD by flow cytometry (10\^-4 sensitivity) in the peripheral blood.
• 4\. Patients who are on BTK inhibitor monotherapy for more than 6 months. This study includes patients who are taking one of the following BTK inhibitors: ibrutinib, zanubrutinib, orelabrutinib, and acalabrutinib.
• 5\. Patients need to have a response of at least PR (CR/PR) to BTK inhibitor monotherapy.
• 6\. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• 7\. Patients must have adequate renal and hepatic function:
• Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;
• Serum creatinine clearance of ≥ 50 ml/min (calculated or measured);
• ALT and AST ≤ 3.0 × ULN, unless clearly due to disease involvement.
• 8\. Adequate bone marrow function:
• Platelet count of greater than 50,000/µl, with no platelet transfusion in prior 2 weeks;
• ANC ≥ 1000/µl in the absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by ≥ 80% CLL in marrow;
• Hemoglobin ≥ 8g/dL.
• 9\. Adequate cardiac function, as assessed by:
• Absence of uncontrolled cardiac arrhythmia;
• Echocardiogram demonstrating LVEF ≥ 35%;
• NYHA functional class ≤ 2.
• 10\. Ability to provide informed consent and adhere to the required follow-up.