OncoMatch/Clinical Trials/NCT06958705
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
Is NCT06958705 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Venetoclax combined with Ibrutinib and Venetoclax combined with Zanubrutinib for chronic lymphocytic leukemia (cll) / small lymphocytic lymphoma (sll).
Treatment: Venetoclax combined with Ibrutinib · Venetoclax combined with Zanubrutinib · Venetoclax combined with Acalabrutinib · Venetoclax combined with Orelabrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib, zanubrutinib, orelabrutinib, acalabrutinib) — monotherapy
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.
Cannot have received: other therapeutic agents for CLL/SLL during BTK inhibitor treatment
Received other therapeutic agents for CLL/SLL during BTK inhibitor treatment prior to enrollment.
Cannot have received: BCL2 inhibitor (venetoclax)
Prior treatment with venetoclax or other Bcl-2 inhibitor.
Cannot have received: strong CYP3A inhibitors
Received strong CYP3A inhibitors ... within 7 days of starting venetoclax.
Cannot have received: strong CYP3A inducers
Received strong CYP3A inducers within 7 days of starting venetoclax.
Lab requirements
Blood counts
Platelet count > 50,000/µl, no platelet transfusion in prior 2 weeks; ANC ≥ 1000/µl in absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by ≥ 80% CLL in marrow; Hemoglobin ≥ 8g/dL.
Kidney function
Serum creatinine clearance of ≥ 50 ml/min (calculated or measured)
Liver function
Serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN for patients with Gilbert's disease; ALT and AST ≤ 3.0 × ULN, unless clearly due to disease involvement.
Cardiac function
Absence of uncontrolled cardiac arrhythmia; Echocardiogram demonstrating LVEF ≥ 35%; NYHA functional class ≤ 2.
Patients must have adequate renal and hepatic function: Serum bilirubin ≤ 1.5 × 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. 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. Adequate cardiac function, as assessed by: Absence of uncontrolled cardiac arrhythmia; Echocardiogram demonstrating LVEF ≥ 35%; NYHA functional class ≤ 2.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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