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NotablePrimary and study completion pushed from Aug 16, 2030 to Sep 30, 2032Interventions: Acalabrutinib (Drug), Investigator's choice of treatment (Other) to Acalabrutinib (Drug), Investigator's choice of treatment (Other) · Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 1 of 5 entries · 1 moreShow 4 more changesShow less
Interventions: Acalabrutinib (Drug), Investigator's choice of treatment (Other) to Acalabrutinib (Drug), Investigator's choice of treatment (Other)
Eligibility criteria expanded, about 28 words
Secondary endpoints: details revised at 1 of 5 entries
Study description expanded, about 8 words
MinorEligibility criteria expanded, about 144 wordsSite details revised at 1 of 23 sitesv17Show 1 more changeShow less
Minor2 versionsRe-verified since Aug 22, 2025, no change to tracked fieldsv9-v10
MinorSite details revised at 1 of 23 sitesv8
MinorSite details revised at 1 of 23 sitesv7
MinorSite details revised at 1 of 23 sitesv6
MinorSite details revised at 1 of 23 sitesv5
MinorCompletion date: Jan 29, 2031 to Aug 16, 2030v4
NotableTrial status: Not Yet Recruiting to RecruitingCompletion date: Dec 25, 2030 to Jan 29, 2031 · Start date changed from estimate of Dec 31, 2024 to Feb 4, 2025 · Site details revised at 23 of 23 sitesv3Show 3 more changesShow less
Completion date: Dec 25, 2030 to Jan 29, 2031
Start date changed from estimate of Dec 31, 2024 to Feb 4, 2025
Site details revised at 23 of 23 sites
NotableStart date: Nov 30, 2024 to Dec 31, 2024Study sites: 22 to 23 · Completion date: Oct 9, 2030 to Dec 25, 2030v2Show 2 more changesShow less
Study sites: 22 to 23
Completion date: Oct 9, 2030 to Dec 25, 2030
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.