AML 17 TRIAL: PATIENT INFORMATION SHEET 4

(Ref: ISRCTN55675535)

For patients aged 7 years and under

Randomisation to FLT3 Inhibitor

To be read by parent / carer

Dear

You have already helped us with this special study, and you have finished your first course of medicines. We are always trying to learn more about leukaemia and how the leukaemia cells go wrong, so we would like to ask you for a bit of extra help.

Please read this information sheet carefully with your parents and talk to us about anything you may be unsure of or need explaining in more detail.

Why am I being asked to take part?

Now that you have finished taking your first medicines, we know that you have some bad cells, and we would like to find a way to make sure they go away. We have a medicine we would like to try. This medicine is called CEP701. We hope that it might be able to help us to stop you getting sick again, but we aren’t sure if it works yet, so we want to give the medicine to some children, and a dummy medicine to other children, and then look at the two groups of children’s cells and see what we should do in future.

What will happen?

If you will agree, we will give you medicine to drink, and not through your wiggly/central line. You will take the drink twice a day at different times while you are having your other medicines, and it will taste fruity.

Will this medicine make me sick?

People usually don’t feel sick with CEP701, but if you do feel sick we will give you another medicine to stop this. This is called an anti-sickness medicine.

Do I have to take part?

No. Just like the rest of the study you do not have to do this if you do not want to, and if you do decide to help us and then change your mind, that’s ok too, and your doctor won’t be cross. If you agree to take part in this bit of the study your mum and dad will be asked to sign a special form.

Thank you for reading this and for thinking about helping us with this part of the study

Please ask any questions you have

Patient Information Sheet 4 Randomisation to FLT Inhibitor 0-7yrs

Version2.0 dated December 2009

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