"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at treatment for acute promyelocytic leukaemia (AML 17)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the treatment for acute promyelocytic leukaemia (APL). This trial is supported by Cancer Research UK.
This part of the trial is particularly focusing on those who are under 60 years old, although some people over 60 years old may take part. It will compare 2 treatments for APL
The aim is to find out which treatment is better for treating APL.
Who can enter
You can enter this trial if you
- Have acute promyelocytic leukaemia (APL)
- Are well enough to be up and about for at least half of the day (performance status 0,1,2)
- Have satisfactory blood results
- Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
- Are at least 16 years of age
You cannot enter this trial if you
- Have another type of cancer at the same time as your leukaemia
- Have another serious medical condition including infection, lung disease and heart disease that cannot be controlled by medication
- Have damage to your nerves (
- Are pregnant or breastfeeding
This is a large national trial that aims to recruit 2,800 patients, in total, with AML and high risk MDS. About 300 of these patients will have acute promyelocytic leukaemia (APL). It is a randomised trial. Neither you nor your doctor will be able to choose which treatment you have.
ATRA is a capsule you take twice a day. After about a month of treatment, you will have a bone marrow test to find out how well it is working. If the leukaemia is not in complete
You start idarubicin on the second day and have it every other day for a total of 4 doses. You have idarubicin through a drip into a vein over about 20 minutes.
In group 1 the consolidation courses are
- ATRA twice a day for 15 days and idarubicin on days 1 to 4
- ATRA twice a day for 15 days and mitoxantrone on days 1 to 5
- ATRA daily for 15 days and idarubicin on day 1
You have mitoxantrone as a drip into a vein over about 30 minutes.
If you are in group 2, the induction course includes ATRA and arsenic trioxide.
You will be asked to fill in questionnaires before you start treatment and at 3, 6, 12 and 24 months after treatment. They will ask how you are feeling and about side effects you have had. This is called a quality of life study.
If you take part in this trial, the researchers will ask your permission to store some of your blood and bone marrow samples. These samples will be stored safely and may be used in the future for research purposes. Studying these samples may help researchers learn more about leukaemia.
If you don’t wish to have your blood and bone marrow samples stored for research, you don’t have to. You can still take part in the trial.
You will have blood tests before each course of treatment.
You will possibly have a bone marrow test after each course of treatment and then every 3 months for 3 years.
You should be able to have all your treatment as an outpatient in this trial, but it is possible that you may have to come into hospital for some of the treatment through a drip.
The most common side effects of the drugs used in this trial are
- Tiredness (fatigue)
- A drop in the blood cells causing an increased risk of infection
- Feeling or being sick
- Hair loss
- Sore mouth and throat
- Shortness of breath
Idarubicin may turn your urine pink or red because it is coloured red. This may happen about 1 to 2 hours after you have the drug and can last for up to 2 days.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor A K Burnett
Professor N H Russell
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/08/025.