Purpose of trial
Treatment for acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma in children and young people is generally successful, with more than 8 in 10 cases being cured. However, the standard treatment causes short-term and long-term side effects. The aim of this trial is to investigate whether modifications to the standard treatment can reduce these side effects and maintain or increase the effectiveness of the treatment in people who have not been treated previously.
Treatment for lymphoblastic lymphoma and acute lymphoblastic leukaemia (ALL) consists of several stages. It is an intensive form of treatment. You spend time in and out of hospital for several months. In each stage, you have chemotherapy. The different chemotherapy drugs are given in different ways. You have some of your treatment intravenously (through a drip into a vein). Other drugs are taken by mouth (tablets or liquid) or given by injection.
The changes being tested include:
- Shortening the course of the steroid dexamethasone given at the beginning of treatment to reduce side effects.
- Changes to the type of treatment given to prevent the disease relapsing (coming back) in the central nervous system (brain and spinal cord), to increase effectiveness and to make the treatment easier.
- Changes to the type and schedule of treatment given at later stages of treatment.
Your doctor can give you more information about the usual schedule of treatment and what these changes might mean for you. They also give you more information about your treatment plan and the drugs you have at each stage.
Some parts of this study are randomised. This means that people are put into 2 groups and given different treatment. One group has the standard treatment. The other group has the modified treatment that is being tested. You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 2640 children and young people are needed for this trial.
You may be able to enter if:
- You have lymphoblastic lymphoma or acute lymphoblastic leukaemia (ALL).
- You are 1-24 years old.
- (If sexually active) you and your partner use reliable contraception during treatment and for up to a month after treatment.
You will not be able to enter if:
- You have Burkitt-like ALL or Philadelphia-positive ALL.
- You have already had treatment for lymphoblastic lymphoma or ALL.
- Certain steroids for up to 1 week are allowed. One dose of methotrexate during lumbar puncture when you were being diagnosed is allowed.
More information about this trial is available at the UK clinical trials gateway.