Randomized Study Comparing Acalabrutinib Monotherapy Versus Investigators Choice Treatment in Adults With Chronic Lymphocytic Leukemia and Moderate to Severe Heart Impairment

What this Trial Is About

Researchers are conducting a global Phase IV randomized study to evaluate the safety and tolerability of acalabrutinib monotherapy compared to investigators choice of treatment in adults with chronic lymphocytic leukemia CLL who also have moderate to severe heart impairment. The study focuses on patients with a left ventricular ejection fraction LVEF below 50%, categorizing cardiac impairment as moderate LVEF > 40% and < 50% or severe LVEF 40%. This trial is conducted in centers with close collaboration between Hematology and Cardiology teams. Participants are randomly assigned to receive either acalabrutinib 100 mg orally twice daily or a treatment chosen by their investigator, such as chlorambucil, venetoclax, ibrutinib, zanubrutinib, rituximab, or obinutuzumab. Treatment cycles last 28 days, with hematology visits starting every 4 weeks for the first eight cycles and then every 16 weeks. Cardiology assessments including consults, ECHO, ECG, Holter monitoring, and cardiac biomarkers occur regularly throughout treatment and annually with cardiac MRI. During the study, participants undergo safety evaluations and response assessments guided by iwCLL 2018 criteria. After treatment ends, safety follow-up visits continue with cardiac monitoring until disease progression, withdrawal, death, or study termination. Patients with disease progression are contacted every 16 weeks for survival status and additional therapy information. The study spans up to four years from the last participants enrollment.

Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure