This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally
twice daily for 24 months and indefinitely if it is in the interest of the patient.
The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice
daily with dose increase to 400 mg twice daily in case of suboptimal response or failure
(excluding patients who will fail for progression to ABP), in a population of patients with
Ph-positive, BCR-ABL positive CML in early CP.