A trial of nilotinib for children and young people with Philadelphia positive leukaemia

You may be able to enter this trial if you

• Are under 18 and have recently been diagnosed with chronic myeloid leukaemia (CML), or have CML that has got worse despite having imatinib or a drug called dasatinib (or you can’t take these drugs because of bad side effects) and is in chronic or accelerated phase or you have acute lymphoblastic leukaemia (ALL) that has got worse or come back despite having standard treatment
• Have leukaemia that has the Philadelphia chromosome (Philadelphia positive)
• Have satisfactory blood test results
• Are well enough to take part (children under 10 must have a Lansky scale score of 50 or more)

You cannot enter this trial if you

• Have a change to a gene called T3151 – you can check this with your doctor
• Have a drug called dasatinib in the 3 days before starting the trial treatment, or imatinib in the 5 days before
• Have a growth factor called Neulasta (a type of GCSF) in the 2 weeks before starting the trial treatment or other growth factors for blood cells in the week before
• Have chemotherapy that could affect your bone marrow in the 2 weeks before you start the trial treatment
• Have not recovered from the side effects of earlier chemotherapy (apart from hair loss) unless they are very mild
• Have had more than 2 weeks of treatment with hydroxyurea for CML or steroids for ALL and this treatment cannot be stopped within a week of starting the trial treatment
• Have had a stem cell transplant in the last 3 months and you have signs of graft versus host disease (your doctor can confirm this)
• Have had radiotherapy in the last 6 weeks that included a large part of your bone marrow, radiotherapy to your brain and spine or to your whole body (TBI) in the last 3 months, or radiotherapy for symptoms in the last 2 weeks
• Take drugs that could affect your heart rhythm or drugs that can affect an enzyme called CYP3A4 and you cannot stop taking them or change to another drug at least 2 weeks before you start the study treatment – it is important that you don’t stop taking any medication without speaking to your doctor
• Have sickness or diarrhoea that cannot be controlled with medication, or other problems with your digestive system system that could affect how you absorb tablets
• Have had pancreatitis (inflammation of the pancreas)
• Have problems with your kidneys, liver or pancreas that are not related to your leukaemia
• Have a serious infection or heart problems that are a cause for concern (the trial doctors can advise you about this)
• Are known to be HIV, hepatitis B or hepatitis C positive
• Are known to be very sensitive to anything in nilotinib, including lactose which is a sugar found mainly in milk