Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)

This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.

Inclusion Criteria:

• Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk AML
• = 20% bone marrow blasts via bone marrow aspiration or biopsy
• The patient has not yet been treated for AML
• 1º or 2º AML patients with high-risk category features
• ECOG PS = 2
• Renal function and liver function limits.

Exclusion Criteria:

• Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
• Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS leukemia
• Prior treatment with deacetylase inhibitors (DACi) including, panobinostat
• Impaired cardiac function
• Female patient who is pregnant or breast feeding
• Male patient who is not willing to use a barrier method of contraception

Other protocol-defined inclusion/exclusion criteria may apply