A trial looking at chemotherapy for children and young people with acute lymphoblastic leukaemia (UKALL 2003)

This trial is looking at different combinations of chemotherapy for children and young people with acute lymphoblastic leukaemia (ALL ).

This trial is for children from 1 year old and young people up to the age of 25. We use the term 'you' in this summary, but of course if you are a parent, we are referring to your child.

Children with ALL usually have treatment with a number of different chemotherapy drugs. Doctors use a number of factors to make treatment decisions, including how well the treatment has worked so far.

Bone marrow tests can show the number of leukaemia cells in the bone marrow. But doctors think a new test on the bone marrow, called MRD, may be better at showing how well leukaemia has responded to treatment. And a way to predict if it is likely to come back again or not.

MRD stands for ‘minimal residual disease’. MRD varies between patients, even when bone marrow samples looked at under a microscope appear to have a similar number of leukaemia cells. This might explain why children and young people in similar situations can respond differently to treatment.

If doctors know whose leukaemia is likely to come back in the future, these patients could have more treatment to try and stop this happening. Likewise, if doctors know which patients have leukaemia that is less likely to come back in the future, they could give less treatment. This means that only patients who really need it will have the more intensive treatment. The treatment used for leukaemia causes some serious side effects, so its important that patients are not given treatment they don’t need.

The aim of this trial is to see if children and young people with ALL and a low MRD reading can safely have less treatment. And to see if children with ALL and a high MRD reading will have a lower risk of the leukaemia coming back if they have more intensive treatment.

Recruitment

Start 01/10/2003

End 31/08/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have acute lymphoblastic leukaemia (ALL)
Are aged between 1 and 25 years old

You cannot enter this trial if you

Are less than 1 year old, or older than 25 years
Have Burkitt-like ALL (B-ALL)
Have an abnormal chromosome called the Philadelphia chromosome in your leukaemia (‘Philadelphia positive ALL’)

Trial design

This is a a phase 3 trial. If you take part, you will be put into 1 of 2 groups. These are low risk and high risk. This will be determined by your age, white blood cell count and how well the treatment has worked after a few weeks.

Plese note - as a number of children and young people have already joined this trial, only the high risk group is now recruiting patients.

Children and young people in the high risk group will have either standard treatment or more intensive treatment. This will be decided at random. Neither you nor your doctor can decide which treatment you have.

You will have a number of drugs, including vincristine, asparaginase, cytarabine, mercaptopurine, methotrexate, doxorubicin, cyclophosphamide, mercaptopurine and daunorubicin. How much you have, and how often you have them, will vary depending on which treatment group you are in.

Hospital visits

Treatment for leukaemia is lengthy, you will be in and out of hospital for up to 2 or 3 years whether you take part in this trial or not. You are not likely to spend any extra time in hospital as a result of taking part in this trial. You may be in hospital for weeks or possibly months at a time, depending on how well the treatment works and what side effects you have.

Your will have some tests before you start the trial and during your treatment. These include a bone marrow test 8 times in about a year. The first 3 are used to see the number of leukaemia cells in the bone marrow. The next 5 are used to measure MRD. Exactly when you have these tests will depend on which group you are in.

Your will have regular blood tests during chemotherapy. You will also have a lumbar puncture as part of the trial.

After you have finished treatment you will see the doctors every month for a year and less often after that. Most doctors will see their patients indefinitely.

Side effects

All the drugs used in this trial have side effects, and some of them can be serious. The most common side effects include

A drop in blood cells causing an increased risk of infection, breathlessness, bleeding problems and tiredness
Hair loss
Sore mouth
Numbness and tingling in hands and feet (peripheral neuropathy)
Change in liver and kidney function
Change in heart rhythm

You doctor will keep a close eye on you for all these side effects and you will have treatment to help with them if necessary.