A trial looking at treatment for acute myeloid leukaemia and high risk myelodysplastic syndrome - non intensive treatment group (AML 16)

Who can enter

You can enter this trial if you

• Have been diagnosed with AML or high risk myelodysplastic syndrome (MDS) (your doctor will be able to explain whether your MDS is high risk or not)
• Are over 60 years of age (younger patients can take part if they not able to take part in the AML 17 trial)
• Have satisfactory blood test results

You cannot enter this trial if you

• Have already had chemotherapy for your AML (apart from treatment with hydroxyurea tablets, or a similar low dose treatment, to control your white cell count)
• Have acute promyelocytic leukaemia
• Are in the blast transformation phase of chronic myeloid leukaemia
• Have another type of cancer at the same time as your leukaemia or MDS (except basal cell skin cancer)
• Are pregnant or breastfeeding

Trial design

This national trial aims to recruit about 2,000 patients with AML and high risk MDS across the UK.

Between 2007 and 2009, this trial looked at a drug called arsenic trioxide. It compared a combination of arsenic trioxide and low dose cytarabine to low dose cytarabine alone. But the researchers found this did not improve treatment and the committee that is set up to monitor the safety of the trial (data monitoring committee) recommended that this comparison should be stopped. The trial is continuing, but looking at different drugs.

The trial is randomised. The people taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you have low dose cytarabine twice a day for 10 days. You have this as an injection under the skin (subcutaneous injection). Then you have no treatment for 4 to 6 weeks. Each 6 to 8 week period is called a cycle of treatment. You have up to 4 cycles of treatment in total.

If you are in group 2, you have clofarabine every day for 5 days. You have this drug through a drip, which will take between 1 and 2 hours each time. Then you have no treatment for 4 to 5 weeks. This 5 to 6 week period is 1 cycle of treatment. You have up to 4 cycles in total. 

If you are in group 3, you have sapacitabine. You take it as capsules twice a day on 3 days a week for 2 weeks, followed by 2 weeks without any treatment. This 4 week period is a cycle of treatment. Initially you have 4 cycles of treatment. You may carry on having sapacitabine if you are responding to the drug. Some people take longer to respond to sapacitabine, so you may have more than 4 initial cycles.

Hospital visits

Before you start your treatment, a doctor will examine you and you will have various tests. These tests will include blood tests, bone marrow tests and scans.

You will have blood tests and possibly a bone marrow test after each cycle of treatment.

If you have cytarabine injections, you may be able to have these at home. A nurse may give you the injections, or you may be able to learn to inject these yourself.

If you have clofarabine through a drip, you will probably be able to have this as an outpatient. There is a possibility that some people may need to stay overnight in hospital.

After your treatment has finished, you will continue to have follow up appointments with your doctor. These appointments will be made on an individual basis.

Side effects

All treatments have side effects. The most common side effects of chemotherapy include

• A drop in the numbers of blood cells, causing increased risk of infection, bleeding problems, tiredness and breathlessness
• Hair loss
• Feeling and being sick
• Constipation
• Diarrhoea
• Sore mouth and mouth ulcers

You can read about the particular side effects of cytarabine on CancerHelp UK.

Clofarabine sometimes causes a rash, particularly on the hands and feet. Your doctor can treat this with steroids if necessary.

As clofarabine and sapacitabine are quite new drugs, there may be some side effects we don't know about yet.