
"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 oral azacitidine alongside best supportive care for acute myeloid leukaemia that has completely disappeared after treatment.
Doctors usually treat acute myeloid leukaemia (AML) with chemotherapy. The aim of treatment is to get your leukaemia into . This means there are no leukaemia cells in your blood or
. The people taking part in this trial have all had successful treatment for AML and are in complete remission.
When you are in complete remission, your doctor will monitor you closely and you have regular tests. You may also have , growth factors to increase the number of blood cells in your bloodstream and drugs such as
to treat infections. This is called best
.
But there is a risk that your leukaemia will come back. This is called a recurrence. Researchers are looking for new treatments to reduce this risk, or at least extend the time before leukaemia comes back. In this trial they are looking at a drug called azacitidine. Doctors can already use azacitidine given into the bloodstream to treat AML in people who can’t have intensive chemotherapy.
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 3 trial will recruit 460 people in different countries. 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. And neither of you will know which group you are in. This is called a double blind trial.
Everybody taking part has . This may include
, growth factors and drugs such as
.
Half the people taking part will also have oral azacitidine. The other half will have a dummy drug (a ).
You usually have azacitidine as an injection just under your skin (subcutaneously). Occasionally you have it through a drip, or as an injection into a vein. But in this trial, the researchers are looking at a tablet form of azacitidine.
You take 2 azacitidine tablets (or dummy tablets) once a day for 2 weeks, followed by 2 weeks without any tablets. Each 4 week period is called a cycle of treatment.
As long as you don’t have bad side effects, you can carry on taking the tablets for as long as they are helping you, or until the end of the trial
The trial team will ask you to fill out two questionnaires before you start treatment, once a month during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The trial team will also give you a diary to keep at home. In this, you write down
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital once a week for the first 8 weeks of treatment, then once every 2 weeks after that. You have regular blood tests. You have a bone marrow test every 3 months.
When you finish treatment, you see the trial team again about 4 weeks later. A member of the trial team will then contact you by phone to see how you are and whether you are having any treatment for AML. They will do this once a month for the 1st year and then once every 3 months after that.
The most common side effects of azacitidine include
The doctor will talk to you about all the possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mike Dennis
Celgene
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
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.”