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

ConditionsChronic Lymphocytic Leukaemia Heart Failure

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-130

SponsorAstraZeneca

About this trial

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%.

Randomisation will be stratified by LVEF \> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows:

Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF \> 40% to \< 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team.

An IDMC will be responsible for making recommendations for study continuation.

Eligibility criteria

Qualifiers

Men and women ≥ 18 years of age, at the time of signing the informed consent.

Eastern Cooperative Oncology Group performance status of 0 to 3

Left ventricular ejection fraction assessed by ECHO < 50%.

Diagnosis of CLL

Disqualifiers

Known active CNS leukaemia, leptomeningeal disease or spinal cord compression. In case of R/R patients with prior history of CNS localisation of leukaemia who received treatment are eligible provided that there is no evidence of CNS involvement at study entry as documented by cerebrospinal fluid (CSF) cytology and/or brain MRI.

Ongoing Richter's transformation.

Prior exposure to a BTKi.

Major surgery within 30 days before first dose of study treatment.