Nilotinib

• Research type

  Research Study

• Full title

  A Phase II Multi-Centre, Open-Label Study Of Nilotinib At A Dose Of 300mg Twice Daily In Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia In Chronic Phase (CML-CP)

• IRAS ID

  1

• Sponsor organisation

  ICORG

• Eudract number

  2008-004551-30

• Research summary

  The study is being done to explore whether the dose of Nilotinib can be safely reduced to 300mg twice daily with the aim of reducing potential side effects without sacrificing its efficacy. The investigators believe that by using Nilotinib instead of Imatinib the participants may obtain more rapid control of their leukaemia and that this may result in better long term control of the disease and possibly even cure. The participant will be required to take two 150mg Tasigna (Nilotinib) capsules twice daily. The first dose should be taken in the morning and the second dose in the evening and it should not be taken with food. For both the morning and evening doses no food or drink should be consumed for 2 hours prior to taking the capsules and for 1 hour after. During the fasting periods water should only be consumed. Prior to entering the study participants will need to have several blood tests taken, a bone marrow test (unless one has already been carried out within 6 weeks), an ECG and an ECHO. On the first day of taking the study medication further bloods tests and an ECG before and after taking the drug shall be carried out. An ECG will also be repeated after 1 week of treatment. Further blood tests will be carried out after 1, 2 and 4 weeks of treatment and then monthly after that. A bone marrow test will be performed every 3 months until a Complete Cytogenetic Response is achieved. Prior to starting treatment blood samples will be sent for molecular analysis (PCR for Bcr-Abl and mutation analysis) and these will be repeated every 3 months. A visit to the Centre shall be required initially at study entry, after 1 month of treatment and then every 3 months. The other visits can be made to your local haematologist. Apart from the ECG and ECHO tests all of the other investigations and procedures are standard practice in caring for CML patients.

• REC name

  HSC REC B

• REC reference

  09/NIR02/1

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Favourable Opinion