Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Inclusion Criteria:

Written informed consent prior to study-specific screening procedures
Life expectancy of ≥ 60 days
Eastern Cooperative Group (ECOG) performance status ≤ 2
Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
Negative serum pregnancy test (within 7 days of first dose)
Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

Known HIV
Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
Patient unable to swallow capsules
Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply