Actively Recruiting
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
Led by Fred Hutchinson Cancer Center · Updated on 2025-11-19
20
Participants Needed
1
Research Sites
427 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meeting published diagnostic criteria
- Active disease requiring treatment with at least one of the following: progressive marrow failure, large or symptomatic spleen, large or symptomatic lymph nodes, rapidly increasing lymphocyte count, or constitutional symptoms
- Relapsed or refractory after at least one prior systemic therapy for CLL/SLL
- Absolute neutrophil count (ANC) of at least 750 cells/microliter or 500 if bone marrow involved
- Hemoglobin level of at least 10 g/dL
- Platelet count of at least 50,000 cells/microliter or 25,000 if bone marrow involved
- Liver enzymes (AST and ALT) no more than 2.5 times the upper limit of normal
- Total bilirubin no more than twice the upper limit of normal unless due to Gilbert's syndrome
- Estimated creatinine clearance of at least 50 mL/min
- ECOG performance status of 0 to 2
- Women of childbearing potential must use effective contraception during treatment and for 30 days after last dose
- Able and willing to participate in all study procedures including swallowing capsules
- Able to understand and provide informed consent
You will not qualify if you...
- Known prolymphocytic leukemia or suspected Richter's transformation
- Disease progression while on a BTK inhibitor or venetoclax
- Prior intolerance to acalabrutinib or venetoclax
- Recent or active other cancers except certain treated types or those disease-free for 2+ years
- Significant heart disease or uncontrolled arrhythmias, recent heart attack within 6 months, or prolonged QT interval
- Gastrointestinal conditions affecting drug absorption or recent bariatric surgery causing absorption issues
- Known allergies to study drugs
- Active bleeding disorders or on certain blood thinners such as warfarin
- Abnormal blood clotting tests exceeding twice the normal limit
- Uncontrolled autoimmune blood disorders
- Recent gastrointestinal ulcers within 3 months
- Use of strong CYP3A4 inhibitors or inducers within 7 days before study drug
- Proton pump inhibitor use for patients taking capsule form of acalabrutinib unless switched to other acid reducers
- Recent significant stroke or brain bleeding within 6 months
- Major surgery within 7 days before starting study drug
- Hepatitis B or C infection with positive PCR tests
- Pregnant or breastfeeding
- Participation in another therapeutic clinical trial
- Active infections including HIV
- History or current central nervous system involvement by CLL
- History of progressive multifocal leukoencephalopathy (PML)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mazyar Shadman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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