RecruitingPhase 4NCT06651970

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

A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment


Sponsor

AstraZeneca

Enrollment

60 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing acalabrutinib (a targeted oral cancer pill) against the doctor's standard choice of treatment for patients with chronic lymphocytic leukemia (CLL) — a slow-growing blood cancer — who also have reduced heart pumping function (heart failure with low ejection fraction). **You may be eligible if...** - You are 18 or older with a confirmed CLL diagnosis - Your heart's pumping ability is below 50% (measured by an echocardiogram) - You have either never been treated for CLL, or your CLL has come back after previous treatment - You have received no more than 2 prior CLL treatments - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your heart pumping function is normal (50% or above) - You have received more than 2 prior CLL treatments - You have a history of certain bleeding problems or are on blood thinners that cannot be safely adjusted - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Acalabrutinib Monotherapy

OTHERInvestigator's choice of treatment

control arm treatment type will be defined by the PI prior to randomisation


Locations(23)

Research Site

Charlotte, North Carolina, United States

Research Site

Columbus, Ohio, United States

Research Site

Philadelphia, Pennsylvania, 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

View Full Details on ClinicalTrials.gov

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NCT06651970


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