Nilotinib vs. standard Imatinib for CML-CP patients.

• Research type

  Research Study

• Full title

  An open label, randomised study of Nilotinib vs. standard Imatinib (400/600 mg QD) comparing the kinetics of complete molecular response for CML-CP patients with evidence of persistent Leukemia by RQ-PCR.

• IRAS ID

  29969

• Contact name

  Brian Huntly

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-012616-40

• Clinicaltrials.gov Identifier

  NCT00760877

• Research summary

  Leukaemia is a cancer of the white blood cells. Normally, white blood cells grow and divide in an orderly and controlled way, but in leukaemia the process gets out of control and the cells divide too quickly, and do not mature properly. Chronic Myeloid Leukaemia (CML) is a rare type of a cancer affecting the myeloid cells (one of the main types of white blood cells); approximately 750 new cases are diagnosed in the UK each year. CML can occur at any age but the main incidence is in adults aged 40-60 years. CML usually develops very slowly, which is why it is called ??chronic?? myeloid leukaemia. There are few noticeable symptoms, however, if left untreated the CML can progress causing large numbers of cancer cells to build up in the bone marrow leading to serious health implications. Most people with CML have a genetic abnormality known as a Philadelphia chromosome, which can be detected by laboratory tests. In turn this creates a new gene, known as BCR-ABL which leads to stimulated production of abnormal blood cells by the bone marrow. Nilotinib is an approved treatment for CML in patients who have previously been treated with imatinib with some effect but who have become resistant or intolerant to the treatment. Novartis Pharmaceuticals is sponsoring a study to determine if nilotinib, in comparison to imatinib, is more effective at reducing BCR-ABL activity to undetectable levels, in participants who have been treated with imatinib for at least 2 years but still have small amounts of BCR-ABL activity. Approximately 192 participants from a number of study centres around the world will be randomly (by chance) assigned to one of two treatment groups at a ratio of 1:1:?½ Nilotinib 400 mg twice a day?½ Imatinib at same dose as received prior to study.Both the study doctor and the participant will know which treatment is being given.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/75

• Date of REC Opinion

  28 Jan 2010

• REC opinion

  Further Information Favourable Opinion