Phase II Study of Acalabrutinib and Venetoclax for Treating Adults with Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What this Trial Is About

Researchers are evaluating the combination of acalabrutinib and venetoclax in adults with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL that has not responded to previous treatments or has returned. This phase II trial aims to study how these drugs may stop cancer cell growth by targeting different pathways. Acalabrutinib blocks enzymes needed for cancer cell growth, while venetoclax works by killing cancer cells or stopping them from dividing or spreading. Participants take acalabrutinib orally twice daily for the first three 28-day cycles. Starting with the fourth cycle, venetoclax is added once daily, and this combined treatment continues every 28 days for up to 26 cycles, unless the disease progresses or side effects become unacceptable. During the study, patients undergo blood tests, bone marrow aspiration and biopsy, and imaging scans such as CT or MRI to monitor their condition. After finishing the treatment phase, patients are followed up every 12 weeks and then annually for up to 10 years to assess long-term effects. Researchers measure the rate of undetectable measurable residual disease at the end of treatment as the primary outcome. Secondary outcomes include response rates, progression-free and overall survival, and treatment toxicity. Participants will be regularly evaluated through clinical assessments and laboratory tests throughout the study duration.

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