A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors

Inclusion Criteria

Inclusion criteria:

- Male or female patients aged ≥ 18 years old

- Diagnosis of Philadelphia chromosome positive accelerated or blast phase chronic
myeloid leukemia defined as:

- Accelerated phase - the presence of at least one of the following:

- ≥15% but <30% blasts in blood or bone marrow

- ≥30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that
<30% blasts present in bone marrow)

- ≥ 20% basophiles in the peripheral blood

- Thrombocytopenia <100 X 109 /L unrelated to therapy

- Blast phase (blast crisis) - the presence of one of the following:

- ≥ 30% blasts in the blood, marrow or both

- Extramedullary infiltrates of leukemic cells

- Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib,
nilotinib, or dasatinib) and demonstrated resistance to the most recent kinase
inhibitor therapy.

- Patients with a history of intolerance to one BCR-ABL kinase inhibitors (defined as
discontinuation of treatment due grade 3 or 4 adverse events related to treatment)
will be considered eligible to enter the study if they demonstrate resistance to
their most recent BCR-ABL kinase inhibitor.

- 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 hematopoitic stem cell transplantation

- Prior therapy with certain medications

- Patients who are in chronic phase chronic myeloid leukemia

- Impaired cardiac function or clinically significant cardiac diseases

- Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or
torsades de pointes

- Concomitant use of certain medications

- Impairment of GI function or GI disease

- Patients with unresolved diarrhea

- Patients who have received chemotherapy, any investigational drugs (other than
BCR-ABL tyrosine kinase inhibitors) 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