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:

  1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 8.0 g/dL.
  2. Serum chemistry: albumin ≥ 3 g/dL; aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to leukemic involvement; bilirubin ≤ 1.5 x ULN; creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 mL/min; potassium, phosphorus, magnesium and total calcium (corrected for serum albumin) or serum ionized calcium ≥ lower limit of normal (LLN), thyroid stimulating hormone (TSH) and free T4 (thyroxine) within normal limits.

Note: Potassium, calcium, and magnesium supplements to correct values that are \< LLN, were allowed when documented as corrected prior to enrollment.

* 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 Eastern Cooperative Oncology Group (ECOG) 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. Therapeutic doses of sodium warfarin or any other anti-vitamin K drug (low doses for line patency were allowed). Prior HDACi treatment of CML, concomitant use of drugs with a risk of causing QT interval (QTc) prolongation or torsades de pointes, CYP3A4/5 inhibitors, anti-cancer therapy or radiation therapy, valproic acid (within 5 days prior to study drug treatment or during the study), chemotherapy or major surgery (within 3 weeks), immunotherapy (within 1 week), BCR-ABL tyrosine kinase inhibitors (TKI) ≤ 1 week of first treatment with panobinostat
* 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