"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 children and young people with acute lymphoblastic leukaemia and lymphoma (UKALL 2011)
This trial is looking at treatment for leukaemia and lymphoma. The children and young people taking part have acute lymphoblastic leukaemia (ALL) or a type of non Hodgkin lymphoma (NHL) called lymphoblastic lymphoma (LBL).
This trial is for children from 1 year old and young people up to the age of 24. We use the term 'you' in this summary, but of course if you are a parent, we are referring to your child.
Doctors treat ALL and LBL with chemotherapy. They use a number of drugs in different combinations. As with all treatments, there are side effects and doctors are always looking for ways to reduce them.
The aims of this trial are to see if changing the standard treatment for children and young people with ALL or LBL will reduce side effects and help stop their disease from coming back.
Who can enter
You may be able to enter this trial if you
- Have acute lymphoblastic leukaemia (ALL) or a type of non Hodgkin lymphoma (NHL) called lymphoblastic lymphoma (LBL)
- Are willing to use reliable contraception during treatment and for a month afterwards if there is any chance you or your partner could become pregnant
- Are between 1 and 24 years old
You cannot enter this trial if you
- Have B cell ALL
- Have ALL that is
Philadelphia chromosome positiveor BCR-ABL positive – your doctor can confirm this
- Have already had treatment for your leukaemia or lymphoma – you may join if you had glucocorticoids (dexamethasone or prednisolone) for no more than 3 days immediately before agreeing to take part in this trial
This is a phase 3 trial. It will recruit 2,640 children and young adults.
Some parts of the trial are randomised. The people taking part will be put into groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Treatment is intensive and will last for several months. It is too complicated to go into detail here, but below is an outline of the trial. Your doctor will be able to tell you more about it.
Your doctor will talk to you about the randomisations when they are due to happen.
You have treatment in 5 stages.
The 1st stage is called induction. The aim is to get rid of the cancer.
After this stage you have a bone marrow test to see how well you responded to induction treatment. This is called a minimum residual disease test (MRD). Your doctor will use the result of the MRD to decide how intensive the rest of you treatment should be.
The 2nd stage is called consolidation. You have more chemotherapy to destroy any remaining cancer cells. It also stops the cancer from spreading to the brain and spinal cord.
The 3rd stage is called interim maintenance. During this stage you have less intensive treatment. This is to give you a break from the intensive treatment. You have chemotherapy tablets to take at home.
The 4th stage is called delayed intensification. It is a combination of the induction and consolidation stages. Doctors use it to destroy any remaining cancer cells that may still be there but can’t be found in tests.
The 5th stage is called maintenance. It reduces the risk of cancer coming back after treatment is finished.
Treatment for leukaemia and lymphoma is very intensive. You will be in and out of hospital for several months whether you take part in this trial or not.
You have many different chemotherapy drugs as part of this trial. The drugs in the trial include
There is information about the side effects of each of these drugs on the links above. But in summary, the most common side effects include
- A drop in blood cells causing an increased risk of infection, bleeding and bruising problems, tiredness and shortness of breath
- Feeling or being sick
- Hair loss
- Loss of appetite
- Sore mouth
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
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 Ajay Vora
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham