OncoMatch/Clinical Trials/NCT04941716
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
Official title: AVENUE-2: Acalabrutinib in Combination With Venetoclax (AV) for Previously Treated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Is NCT04941716 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Acalabrutinib and Venetoclax for recurrent chronic lymphocytic leukemia.
Treatment: Acalabrutinib · Venetoclax — This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — CLL/SLL
Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current National Comprehensive Cancer Network (NCCN) guidelines, or of an investigational regimen on a clinical trial.
Cannot have received: BTK inhibitor
Exception: prior disease progression while on a BTK inhibitor
Prior disease progression while on a BTK inhibitor
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: prior disease progression while on venetoclax
Prior disease progression while on venetoclax
Cannot have received: BTK inhibitor (acalabrutinib)
Exception: prior intolerance to acalabrutinib
Prior intolerance to acalabrutinib
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: prior intolerance to venetoclax
Prior intolerance to venetoclax
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 750 cells/microliter (0.75 x 10^9/L); ANC >= 500 cells/microliter (0.50 x 10^9/L) in subjects with documented bone marrow involvement of CLL; Hemoglobin >= 10 g/dL; Platelet count >= 50,000 cells/microliter (50 x 10^9/L); platelet count >= 25,000 cells/microliter (25 x 10^9/L) in subjects with documented bone marrow involvement of CLL
Kidney function
Estimated creatinine clearance of >= 50 mL/min
Liver function
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN); Total bilirubin <= 2 x ULN, unless directly attributable to Gilbert's syndrome
Absolute neutrophil count (ANC) >= 750 cells/microliter (0.75 x 10^9/L); ANC >= 500 cells/microliter (0.50 x 10^9/L) in subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening). Hemoglobin >= 10 g/dL (independent of growth factor or transfusion support within 1 week of screening). Platelet count >= 50,000 cells/microliter (50 x 10^9/L); platelet count >= 25,000 cells/microliter (25 x 10^9/L) in subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening). Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN). Total bilirubin <= 2 x ULN, unless directly attributable to Gilbert's syndrome. Estimated creatinine clearance of >= 50 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04941716 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BTK inhibitor, BCL2 inhibitor, BTK inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify