Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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. 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Diagnoza białaczki limfocytowej (CLL)
- •Problemy z sercem: zmniejszona siła skurczów serca, historia niewydolności serca, choroba niedokrwienna serca, kardiomiopatia, zaburzenia rytmu serca lub choroby zaworów serca
- •Choroba aktywna wymagająca leczenia
- •Brak wcześniejszego leczenia lub co najwyżej 2 poprzednie leczenia
- •Wystarczająca liczba białych krwinek i płytek krwi
- •Prawidłowa funkcja wątroby i nerek
- •Zgoda na stosowanie antykoncepcji (dla osób mogących mieć dzieci)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 130 Years
- Last updated (source)
- August 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (23)
Research Site
Charlotte, United States
Research Site
Columbus, United States
Research Site
Philadelphia, United States
Research Site
Brno, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Prague, Czechia
Research Site
Cagliari, Italy
Research Site
Florence, Italy
Research Site
Milan, Italy
Research Site
Milan, Italy
Research Site
Pavia, Italy
Research Site
Perugia, Italy
Research Site
Krakow, Poland
Research Site
Poznan, Poland
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Seville, Spain
Research Site
Bournemouth, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Plymouth, United Kingdom
Research Site
Romford, United Kingdom
Research Site
Stockton, United Kingdom
Research Site
Sutton Coldfield, United Kingdom
Trial contact
AstraZeneca Clinical Study Information Center
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/15/2026.
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