
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at switching treatment and then stopping treatment for chronic myeloid leukaemia (CML).
Doctors often treat CML with a biological therapy called imatinib (Glivec). Imatinib is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. We know from research that CML responds to it so well in some people, that they can stop taking imatinib.
Nilotinib (Tasigna) is another biological therapy that is also a cancer growth blocker. We know from research that CML may respond better to nilotinib than imatinib.
The main aims of this trial are to find out
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply
This is a phase 3 trial. The researchers need 1,058 people to join.
There are 2 parts to this trial. In the 1st part everyone takes nilotinib for 2 years. If your CML has a good response to nilotinib you can go on to the 2nd part. If your CML doesn’t respond well enough, your doctor will talk to you about other treatment.
The 2nd part is randomised. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This part of the trial continues for 3 years. This makes a total of 5 years in the trial.
Nilotinib is a capsule that you take twice a day with a glass of water. Your doctor will tell you how many you need to take.
In the 1st part of the trial, the team will ask you to fill out a questionnaire before you start treatment, after 6 months and then at 2 years. In the 2nd part they will ask you to fill out the same questionnaire every 6 months for 3 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The team are also doing a sub study within this main study. They may ask you if you would like to take part, but you don’t have to agree to this if you don’t want to.
In this sub study the researchers are looking at the importance of leukaemic stem cells in the long term in CML.
Stem cells are immature cells in your bone marrow. Normally they develop into red blood cells, white blood cells or platelets. In CML too many stem cells become an abnormal type of white blood cell that doesn’t develop into a healthy white blood cell.
For this sub study the researchers will take a before you start nilotinib and after 2 years of taking it. If you are in the group that continues to have nilotinib for another year, the researchers will take another bone marrow sample at the end of this year too.
You see the doctor to have some tests before taking part in this trial. These tests include
During the trial you see the doctor regularly for a physical examination, blood tests and a heart trace.
At the end of the 5 years you see the doctor for the same tests.
The most common side effects of nilotinib include
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have more information on nilotinib side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Jane Apperley
Novartis
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”