A Phase II study in adult patients with newly diagnosed chronic-phase chronic myeloid leukaemia of initial intensified imatinib therapy and sequential dose-escalation followed by treatment with nilotinib in suboptimal responders to determine the rate and duration of major molecular response

All patients commence imatinib at 600 mg/day. Dose is escalated to 800 mg/day if the trough imatinib plasma level is less than 1000 ng/ml on day 22. Dose is increased to 800 mg/day if the Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) values of BCR-ABL are >10% at 3 months, >1% at 6 months or >0.1% at 12 months. Dose is switched to nilotinib 400 mg/day if a patient is unable to dose escalate to 800 mg after 1 month of trying or if the BCR-ABL value is >10% at 6 months, >1% at 9 months or >0.1% at 15 months.