RecruitingPhase 2NCT06757647

Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Prospective Phase 2 Study of the Effect of Acalabrutinib on Myocardium on Ibrutinib Exposed Patients With CLL

Sponsor

Seema Bhat

Enrollment

61 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary

This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether acalabrutinib — a targeted therapy that blocks a protein cancer cells use to survive — is safe and effective for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who developed heart-related side effects (such as irregular heartbeat) while on another similar drug called ibrutinib. **You may be eligible if...** - You are 18 or older with a confirmed CLL or SLL diagnosis - You developed a heart rhythm problem (like atrial fibrillation) while taking ibrutinib and had to stop it - You are in reasonably good health with adequate blood, kidney, and liver function **You may NOT be eligible if...** - You have previously taken acalabrutinib - Your disease worsened while on ibrutinib - You have significant heart disease (history of heart attack, heart failure, or severe arrhythmias) - You are pregnant or breastfeeding - You have active HIV, uncontrolled infection, or active hepatitis B or C - You require blood thinners like warfarin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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