Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy

Inclusion Criteria:

1. Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) or accelerated phase
(AP)with resistance to at least one prior BCR-ABL targeting TKI

2. Documented chronic phase CML

3. Adequate end organ function

4. Female patients of childbearing potential must have a negative serum pregnancy test
and must be using highly effective methods of contraception. Male patients with
female partners of child-bearing potential must use condoms.

Exclusion Criteria:

1. Impaired cardiac function

2. Severe and/or uncontrolled concurrent disease that in the opinion of the investigator
could cause unacceptable safety risks or compromise compliance with the protocol

3. History of acute pancreatitis within 1 year of study entry or past medical history of
chronic pancreatitis

4. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers,
and the treatment cannot be either discontinued or switched to a different medication
prior to entering the study

5. Patients who are currently receiving treatment with any medications that have the
potential to prolong the QT interval and the treatment cannot be either safely
discontinued or switched to a different medication prior to starting study drug.

6. Previously documented BCR-ABL Y253H, E255K/V, T315I or F359C/V mutation

Other protocol-defined inclusion/exclusion criteria may apply.