Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
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)
Eligibility 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.
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
