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

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of chronic lymphocytic leukaemia (CLL). You must also have some weakness in your heart, meaning its pumping ability is less than 50%. The study is open to people who are either newly diagnosed with CLL or have had treatment before but no more than two different types of systemic treatment. Your CLL also needs to be active and require treatment, and you should generally feel well enough to participate in daily activities.

There are also some important blood test results you'd need to meet, for example, your blood counts (like white blood cells and platelets) and liver and kidney function. If you could become pregnant or get someone pregnant, you would need to agree to use effective contraception during the study and for a short time afterwards.

You wouldn't be able to join if your leukaemia has spread to your brain or spinal cord, if you have a different, more aggressive type of blood cancer called Richter's transformation, or if you've already taken a similar type of leukaemia drug called a BTK inhibitor. Recent major surgery would also prevent you from joining right away.

If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive acalabrutinib, which is a tablet you take by mouth twice a day. The other group will receive a standard CLL treatment chosen by your doctor from a list of approved medications like chlorambucil, venetoclax, ibrutinib, zanabrutinib, rituximab, or obinutuzumab. You'll continue treatment for as long as it's working and you're not experiencing severe side effects.

Throughout the study, you'll have regular visits to the hospital, usually on the first day of each 4-week treatment cycle for the first eight cycles, and then every 16 weeks after that. At these visits, you'll have blood tests, a physical exam, and your overall health will be checked. Your doctors will also assess how well the treatment is working for your leukaemia every 16 weeks.

Crucially, because this study focuses on heart health, you'll have frequent heart checks. This includes a heart doctor's visit, heart scans (like ECHO and ECG), 24-hour heart monitoring, and blood tests for heart markers, especially at the start, after a few cycles, and every 16 weeks. A more detailed heart MRI scan will be done once a year. If your treatment needs to be adjusted due to heart-related issues, your study doctor will discuss this closely with a heart specialist. After you stop treatment, you'll have a follow-up visit within 45 days for more heart and safety checks, and then continued safety monitoring until your leukaemia progresses or the study ends.