Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase

Inclusion criteria:

• Male or female patients aged ≥ 18 years old
• Diagnosis of Philadelphia chromosome positive, chronic phase chronic myeloid leukemia
• Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors with demonstrated resistance to the most recent kinase inhibitor therapy.
• Patients with a history of intolerance to one BCR-ABL kinase inhibitors will be considered eligible to enter the study if they demonstrate resistance to their most recent BCR-ABL kinase inhibitor.
• Patients who are intolerant of at least 2 BCR-ABL kinase inhibitors will be considered eligible to enter this study if they also demonstrate resistance to or intolerance of interferon-alpha (IFN-α) by the same criteria defined above.
• Patients must have adequate laboratory values
• Baseline measurement of left ventricular ejection fraction [assessment of the hearts ability to pump effectively]
• Assessment of patients ability to perform every day activities. Assessment by the ECOG [Eastern Cooperative Oncology Group] Performance Status

Exclusion criteria:

• A candidate for hematopoietic stem cell transplantation
• Prior therapy with certain medications
• Patients with a prior history of accelerated phase or blast crisis CML
• Impaired cardiac function or clinically significant cardiac diseases
• Concomitant use of certain medications
• Impairment of GI function or GI disease
• Patients with unresolved diarrhea
• Patients who have received chemotherapy, any investigational drugs or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Patients who have received a BCR-ABL tyrosine-kinase inhibitor within 1 week of first treatment with LBH589
• Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control
• Male patients whose sexual partners are women of child bearing potential not using effective birth control

Other protocol-defined inclusion/exclusion criteria may apply