Study Comparing Acalabrutinib Alone to Other Treatments in Patients with Chronic Lymphocytic Leukemia and Heart Failure
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06651970
This clinical trial is testing the safety and tolerability of acalabrutinib, a medication taken by mouth, compared to other treatments chosen by doctors for patients with chronic lymphocytic leukemia (CLL) who also have moderate to severe heart failure.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate how safe and tolerable acalabrutinib is when used alone compared to other treatments for patients with CLL who have heart problems. Patients will be randomly assigned to receive either acalabrutinib or a treatment chosen by their doctor. The study will take place in about 20 centers worldwide, where there is close collaboration between heart and blood cancer specialists. Patients will be monitored closely for heart health and overall safety throughout the study.
Description
In this study, patients with CLL and heart failure will receive either acalabrutinib or another treatment chosen by their doctor. The treatment will continue until the patient experiences unacceptable side effects or the disease progresses. Each treatment cycle lasts 28 days, and patients will have regular check-ups, including blood tests and physical exams, at the start of each cycle for the first eight cycles, and then every four cycles after that.
Heart health will be closely monitored with tests like echocardiograms, ECGs, and heart biomarker tests at specific intervals. If any heart-related side effects occur, the treatment may be adjusted or stopped based on the doctor's advice.
After stopping treatment, patients will have a follow-up visit within 45 days to check their heart health and overall safety. These follow-ups will continue every 16 weeks until the disease progresses or the study ends. Patients will also be contacted every 16 weeks to check on their survival status and any new cancer treatments they may be receiving.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Have a performance status that allows for daily activities with some limitations.
- Have a heart function measurement (LVEF) of less than 50%.
- Diagnosed with CLL and either have not been treated before or have relapsed after up to two previous treatments.
- Have active disease that requires treatment.
- Meet specific blood test criteria for neutrophil and platelet counts, liver function, and kidney function.
- Agree to use effective contraception during the study and for two days after the last dose of acalabrutinib.
- Willing to follow the study schedule and provide informed consent.
Exclusion Criteria
- Active cancer in the central nervous system or spinal cord issues.
- Ongoing transformation of CLL to a more aggressive form.
- Previous treatment with a BTK inhibitor.
- Recent major surgery or uncontrolled anemia.
- Recent use of investigational drugs or live vaccines.
- History of certain other cancers unless treated and inactive for over three years.
- Difficulty swallowing pills or significant digestive issues.
- Active infections or history of certain viral infections.
- Recent stroke or bleeding disorders.
- Need for certain blood thinners or medications that affect liver enzymes.
- Pregnant or breastfeeding women.
- Participation in another clinical trial.
- Uncontrolled heart or blood pressure issues.
- Any other serious health conditions that could affect safety or study participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 28204 | Charlotte | North Carolina |
| Research Site | 43210 | Columbus | Ohio |
| Research Site | 19104 | Philadelphia | Pennsylvania |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.