
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing a new drug called asciminib with bosutinib for chronic myeloid leukaemia (CML).
It is for people who have had already treatment with 2 or more drugs such as imatinib, dasatinib or nilotinib.
Doctors often treat CML with targeted cancer drugs such as imatinib or nilotinib. These are a type of cancer growth blocker called tyrosine kinase inhibitors (TKI’s). They stop signals that cancer cells use to divide and grow. But sometimes they stop working or the treatment may not be tolerated very well.
If this happens you might then have a newer type of tyrosine kinase inhibitor called bosutinib. But doctors are always looking for ways to improve treatment. In this study, they are looking at a new drug called asciminib (ABL001).
Asciminib is also a type of tyrosine kinase inhibitor. But it works in a slightly different way. Doctors think that asciminib may improve treatment. But they aren’t sure, so want to find out more.
The aims of the study are to:
The following bullet points list the key entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. Or want to know more on the full entry conditions. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply.
You:
Who can’t take part
You cannot join this study if any of these apply.
You:
This phase 3 study is taking place worldwide. The study team need 222 people to join.
It is a randomised study. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. But you will know which treatment you are having.
You are two times more likely to have asciminib than bosutinib.
Bosutinib and asciminib are tablets. You take asciminib twice a day, everyday on an empty stomach.
You take bosutinib once a day, everyday with food.
You might start having asciminib if you take bosutinib and it stops working.
You have treatment for up to 2 years for as long as it is working and you can tolerate it. You stop treatment if it isn’t working or you are not tolerating the treatment. Your doctor will talk to you about other treatment options.
Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
The researchers will ask for a sample of your bone marrow. They will also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to look at:
You’ll see a doctor and have some tests before you start treatment. The tests include:
You take your treatment at home. You see the doctor for a check up:
The study doctor will phone you a month after treatment finishes to see how you are getting on. They will continue to follow you up every 3 months for up to 5 years.
As asciminib is a new drug, there might be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.
The most common side effects of asciminib we know about from early studies so far include:
The most common side effects of bosutinib include:
The study doctor will talk to you about all the side effects of treatment. We have more information about bosutinib.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof. Adam Mead
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.