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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cytarabine; Idarubicin; Panobinostat

Criteria

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