A study looking at treatment for older adults with acute lymphoblastic leukaemia (UKALL60+)

This phase 2 study will recruit about 148 people. Everybody joining the trial takes steroid tablets for up to a week. During this time, your doctor will decide the best chemotherapy treatment for you to have. There are 4 different treatment plans you can have as part of this trial and each plan is made up of different phases. The possible phases are

• Induction – this aims to get rid of the leukaemia cells
• Intensification – this aims to stop leukaemia cells getting into the fluid around your brain and spinal cord
• Consolidation – this aims to stop the leukaemia coming back
• Maintenance treatment – this aims to stop leukaemia coming back in the long term

The details of each treatment plan are too complicated to go into detail about here. The outlines of the different plans are below. The study team will tell you more about the drugs you will have and how you have them.

People who have ALL with a change to a specific gene which doctors describe as being Philadelphia positive have a treatment plan that is made up of 8 weeks induction treatment, 4 weeks consolidation treatment and then maintenance treatment for 2 years.

If your ALL is not Philadelphia positive, you have 1 of the other 3 treatment plans. Two of the plans are very similar and are called intensive treatments.

In one of them you have induction treatment for 8 weeks, intensification for 4 weeks, consolidation for 12 weeks and then maintenance treatment for 2 years.

In the other one, you have induction treatment for 8 weeks, no intensification treatment, consolidation for just 8 weeks and then maintenance treatment for 2 years.

The 4th treatment plan is less intensive and may be suitable for you if your doctors don’t think you are well enough to have either of the treatments above. With this plan, you have induction treatment for 8 weeks, consolidation for 4 weeks and then 2 years of maintenance treatment.

Some people joining the study will not have any of the treatment plans above. They will have the treatment that people usually have for ALL at the hospital where they are being treated. By joining the study, they allow the researchers to collect information about the treatment they have and how they get on.

Questionnaires 

The study team will ask you to fill out 4 questionnaires before you start treatment, at different times during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling.  The questionnaires are called quality of life studies.

Cheek swab 

The study team will also ask if you would be willing to have a swab taken from the inside of your cheek (a buccal swab).  This provides them with a sample of cells so they can look at your DNA . Looking at the DNA can help the researchers learn more about why some people develop ALL. You do not have to have the buccal swab done if you don't want to, you can still take part in the study.

Patient diary

You have a diary and the trial team will ask you to keep a record of when you take each drug. You return the diary to the trial team when you finish the trial.