Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of deferasirox for people with myelodysplastic syndrome (TELESTO)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This is a trial to see if deferasirox (pronounced de-fer-a-sir-ox) helps people with myelodysplastic syndrome who have too much iron in their blood due to a lot of blood transfusions.
Myelodysplastic syndrome (MDS) is a condition affecting the
Depending on the number of abnormal cells in your bone marrow, doctors work out if there is a low, medium (intermediate) or high risk of your MDS becoming leukaemia. This trial is for people who have low or intermediate risk MDS.
MDS can lead to problems such as infections, bleeding and a low number of red blood cells (
In this trial, the researchers are looking at an iron chelator that you can take by mouth. It is called deferasirox or Exjade. It is already licensed to treat iron overload. The aim of this trial is to find out if it helps people with MDS.
Who can enter
You can enter this trial if you
- Have low or intermediate risk
MDS(your doctor can confirm this for you)
- Have already had more than 15 units of blood and your doctors expect you to need at least 8 blood transfusion each year
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use a reliable form of contraception during the trial and for 4 weeks afterwards if there is any chance you could become pregnant
- Are at least 18 years old and weigh between 35kg and 135kg
You cannot enter this trial if you
- Have been having blood transfusions for more than 3 years
- Have already been having treatment with an iron chelator for more than 6 months
- Have scarring (cirrhosis) of the liver
- Are taking part in any other clinical trial except for an observational study
- Have had another experimental drug in the last 4 weeks (or in the last 7 days if it was something you apply to your skin)
- Have had cancer in the last 5 years apart from basal cell skin cancer or carcinoma in situ of the cervix
- Have heart failure, or your heart is not pumping very strongly (you have a scan of your heart to test this)
- Have another serious medical condition that could affect you taking part in this trial
- Have active hepatitis B or hepatitis C
- Are HIV positive
- Are pregnant or breastfeeding
This is an international trial. It will recruit about 630 people around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a double blind trial.
People in 1 group take deferasirox tablets once a day. The trial doctors will work out the right dose for you according to how much you weigh and tell you exactly how many tablets to take. You have to mix the tablets into a glass of water or fruit juice before swallowing them.
People in the other group take dummy tablets (
You take the tablets for between 3 and 5 years. This will depend on how many people have joined the trial before you. The trial team estimate that it will take about 2 years to recruit enough people. Those joining at the beginning will take the tablets for longer than people joining later on. During the trial, the doctors may change your dose depending on your blood test results.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination including eye and hearing tests
- Heart trace (
- Heart ultrasound (
- Blood and urine tests
- Ultrasound scan of your liver
- Bone marrow test (if you have not had one in the last 6 months)
You see the trial doctors at least once every 4 weeks, more often in the first month of treatment. During the trial you have more blood tests, ECGs, echocardiograms, eye and hearing tests. Your doctors may want you to have more bone marrow tests, ultrasound scans or chest X-rays.
When you finish treatment, a member of the trial team will phone you 4 weeks later to see how you are. The trial team will continue to follow your progress by phone every 6 months until the study is completely over.
If you decide to stop having the trial treatment early, or have to stop because of side effects, the trial team would like to continue to monitor your condition. You will have blood tests, an ECG and echocardiogram every 3 months, as well as eye and hearing tests once a year. If you no longer want to attend these visits, they will contact you by phone to see how you are every 6 months until study is completely over.
How to join a clinical trial
Dr Paresh Vyas
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer