ELEVATE
Research type
Research Study
Full title
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
IRAS ID
1009714
Contact name
Lynne Jordan
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Chronic Lymphocytic Leukaemia (CLL) is a type of cancer that develops slowly. In people with CLL, the bone marrow is not able to control the growth of a type of white blood cell called lymphocytes. This can cause symptoms such as frequent infections, swollen lymph nodes, and tiredness. In people with CLL, the cancer cells are mostly in the blood and bone marrow.
Some treatments for CLL have caused serious, life-threatening heart problems. People with CLL who already have heart disease may not be able to take these treatments. Researchers think the trial drug, acalabrutinib, may be a safe CLL treatment for people with heart problems.
Acalabrutinib is designed to kill blood cancer cells by stopping certain proteins that help these cells live and grow. In this trial, researchers want to learn if acalabrutinib is a safe treatment option for people with CLL and heart disease. Acalabrutinib is approved by health authorities for the treatment of CLL.
In this study, approximately 60 eligible patients will be randomly assigned to receive either 100 mg of acalabrutinib to be taken twice a day or another treatment of their doctor's choosing. If patient passes screening they will have a study visit once every 28 days for 8 cycles (each 28 day period is called a cycle) and then every 4 cycles thereafter.
Study duration will be approximately 6 years and the treatment duration for Arm A (acalabrutinib
monotherapy) will be until disease progression or unacceptable toxicity and for Arm B (doctor choice of treatment) ( until completion of fixed duration treatment per investigator’s choice, or unacceptable toxicity, or disease progression, whichever occurs first.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0087
Date of REC Opinion
9 Jul 2024
REC opinion
Further Information Favourable Opinion