NCT06651970 · AstraZeneca
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
What this study is about
This will be a global Phase IV, where both patients and doctors know the treatment given, randomised study to evaluate the safety and how well patients handle the treatment of acalabrutinib (treatment given alone, 100 mg taken by mouth \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment.
View original scientific description
This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \< 50%.
Interventions
DRUG
Acalabrutinib
Acalabrutinib Monotherapy
OTHER
Investigator's choice of treatment
control arm treatment type will be defined by the PI prior to randomisation
Primary outcome 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 Adverse events of special interest (AESI) defined per Acalabrutinib IB
Safety endpoints 5: To evaluate the frequency of AESI per Acalabrutinib IB after acalabrutinib treatment compared to investigators choice of treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women ≥ 18 years of age, at the time of signing the informed consent. 2. Eastern Cooperative Oncology Group performance status of 0 to 3 3. Left ventricular ejection fraction assessed by ECHO \< 50%. 4. Diagnosis of CLL 5. Treatment naïve or relapsed/refractory patients who received no more than 2 prior lines of systemic anti-CLL treatment. 6. Active disease per iwCLL 2018 criteria that requires treatment. 7. Meet the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 500 cells/μL (0.50 × 109/L). 2. Platelet count ≥ 30,000 cells/μL (30 × 109/L). 3. Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN. 4. Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome. 5. Estimated creatinine clearance (ie, estimated glomerular filtration rate \[eGFR\] using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN. 8. Women and men who are sexually active and can bear children must agree to use highly e
Where
- Charlotte, North Carolina
- Columbus, Ohio
- Philadelphia, Pennsylvania
Collaborators
Fortrea, CALYX Inc., eResearch Technology, Inc., CISCRP
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations