Acalabrutinib for Chronic Lymphocytic Leukemia with Heart Failure
This study is for people with chronic lymphocytic leukemia (CLL) and heart failure. It compares acalabrutinib (a medication taken by mouth) to treatments chosen by your doctor, which could include chlorambucil, venetoclax, ibrutinib, zanabrutinib, rituximab, or obinutuzumab. The main goal is to see if acalabrutinib causes fewer heart-related side effects that lead to stopping treatment, and how long people stay on treatment before stopping due to heart issues. Researchers will also track serious and fatal heart problems. You may be able to join if you are 18 or older, have CLL, and your heart's pumping ability (Left Ventricular Ejection Fraction or LVEF) is less than 50%. This study is currently unclear on its recruitment status and plans to enroll about 60 participants.
- Study design
- This is an open-label, randomized study comparing acalabrutinib to other treatments chosen by your doctor. About 60 participants will be enrolled globally.
- What's involved
- You will have visits every 4 weeks for the first 8 cycles, then every 16 weeks. These visits include physical exams, blood tests, and heart assessments like ECHO, ECG, and Holter monitoring.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to 4 years from the last participant joining the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
At a glance
Conditions
NCT06651970
Where you'd take part
This study runs at 23 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Research Site
Columbus, Ohiono site contact published
Recruiting
Research Site
Philadelphia, Pennsylvaniano site contact published
Recruiting
Research Site
Brno, Czechiano site contact published
Recruiting
Research Site
Prague, Czechiano site contact published
Recruiting
Research Site
Cagliari, Italyno site contact published
Recruiting
Research Site
Florence, Italyno site contact published
Recruiting
Research Site
Milan, Italyno site contact published
Recruiting
Research Site
Milan, Italyno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety endpoints 1: To evaluate the incidence of CV (CardioVascular) adverse events leading to drug discontinuation after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Frequency and time to discontinuation of any study treatment due to worsening in cardiovascular function or cardiovascular AEs.
- Safety endpoints 2: To evaluate the duration on treatment prior to drug discontinuation due to CV adverse events after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence of Grade 4 and 5 cardiovascular events of interest.
- Safety endpoints 3: To evaluate the incidence of life threatening and fatal cardiac events of interest after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence and relationship to study treatment of Grade ≥ 3 AEs.
- Safety endpoints 4: To evaluate the frequency of grade≥3 Adverse events after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence and relationship to study treatment
- Safety endpoints 5: To evaluate the frequency of AESI per Acalabrutinib IB after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence and relationship to study treatment of Non-cardiovascular AE that led to discontinuation of any study treatment.
- Safety endpoints 6: To evaluate the rate of discontinuation due to non-CV adverse events after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence and relationship to study treatment of Events of clinical interest (ECI) per acalabrutinib IB
- Safety endpoints 7: To evaluate the rate of any serious adverse event after acalabrutinib treatment compared to investigators choice of treatment.Visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Incidence and relationship to study treatment of Serious adverse events (SAEs).