PhaseIII Ponatinib vs Imatinib in Chronic CML 05Jul2012 Version 2.0

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

• IRAS ID

  110046

• Contact name

  Richard Clark

• Contact email

  R.E.Clark@liverpool.ac.uk

• Sponsor organisation

  Ariad Pharmaceuticals

• Eudract number

  2012-001355-38

• Research summary

  Over a decade ago, the treatment of chronic myeloid leukaemia (CML) was transformed by the drug imatinib (Glivec). However, we have since learnt that up to 40% of patients do not respond well to imatinib, or lose an initial response. In recent studies, the new drug ponatinib gives encouraging results in CML patients in whom imatinib is no longer effective (resistance) or where it causes unacceptable side effects (intolerance). There are also several reasons why ponatinib might be a better drug than imatinib if used from the initial diagnosis of CML. This will be tested in this trial, which will randomly assign newly diagnosed CML patients to either ponatinib or imatinib.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0629

• Date of REC Opinion

  4 Oct 2012

• REC opinion

  Further Information Favourable Opinion