RecruitingPhase IV🇵🇱 PolandEN originalLeukemia

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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