Trial Search Results
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 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.
Stanford is currently not accepting patients for this trial.
- Drug: Panobinostat
- 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.
- 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
- 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
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study