Safety and Efficacy of CML Patients Who Switch to Nilotinib and Stop Treatment After Achieving and Sustaining MR4.5.

Inclusion Criteria:

- Diagnosis of CML

- Treated with at least 1 year of imatinib

- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by
PCR reported on the International scale. This will be confirmed during screening

- Written informed consent obtained prior to any screening procedures performed

Exclusion Criteria:

- T315I mutation

- Prior imatinib failure or had accelerated phase or blast crisis CML

- Impaired cardiac function (defined futher in the protocol)

- Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply.