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

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. Patients with moderate to severe cardiac impairment will include those with moderate to severe cardiac conditions, who may have been excluded from previous acalabrutinib clinical trials and in whom the safety of acalabrutinib was not systematically assessed. The study is planned to take place in approximately 25 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.

NCT Number	NCT06651970
Lead Sponsor	AstraZeneca Collaborators: Fortrea, CALYX Inc., eResearch Technology, Inc., CISCRP
Conditions	Chronic Lymphocytic Leukaemia, Moderate to Severe Cardiac Impairment
Enrollment	60 participants
Start Date	2025-02-04
Primary Completion	2030-08-16 (estimated)
Study Completion	2030-08-16 (estimated)
Updated on ClinicalTrials.gov	2026-08-14