OncoMatch/Clinical Trials/NCT03128879
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
Is NCT03128879 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ibrutinib and Venetoclax for chronic lymphocytic leukemia.
Treatment: Ibrutinib · Venetoclax · Acalabrutinib — This is a single center, open-label, phase II study of venetoclax (ABT-199) added to ibrutinib or acalabrutinib in patients with high-risk CLL who have received at least 12 months of ibrutinib or acalabrutinib monotherapy. The study will estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable CLL after receiving ibrutinib or acalabrutinib for at least 12 months and who have high risk CLL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: TP53 mutation
mutated TP53
Required: CHROMOSOME 17 deletion (del(17p))
del(17p)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib, acalabrutinib)
Patients must have received at least 12 months of ibrutinib or acalabrutinib therapy
Cannot have received: BCL2 inhibitor (venetoclax)
Prior treatment with venetoclax or other Bcl-2 inhibitor
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 ≥8mg/dL.
Kidney function
Serum creatinine clearance of 50ml/min (calculated or measured).
Liver function
Serum bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease; ALT and AST ≤3.0 x 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 x ULN or ≤3 x ULN for patients with Gilbert's disease. Serum creatinine clearance of 50ml/min (calculated or measured). ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement. Adequate bone marrow function: 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 ≥8mg/dL. INR <1.5. 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.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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