Clinical trial NCT00449761 (phase 2/phase 3, status: completed)
Conditions: leukemia, myeloid, chronic
ICD codes: C92.11, C92.12, C92.21, C92.22, C92.10, C92.20
Drugs: panobinostat
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Eligibility 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