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

Novartis

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Drug: Panobinostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01242774

CLBH589G2101

2009-016809-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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