Clinical Trial

Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2021-06-21; most recent amendment 2026-05-15.
Status change: Not Yet Recruiting → Recruiting 2023-05-08
Trial Details
NCT Number NCT04941716
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: AstraZeneca
Conditions Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
Enrollment 20 participants
Start Date 2023-05-31
Primary Completion 2027-08-10 (estimated)
Study Completion 2031-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-18