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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : panobinostat
Phase: Phase 1
Ages Eligible For Study:
- 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.