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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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


Rondeep Brar
Rondeep Brar
Hematologist, Leukemia specialist, Medical oncologist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology
Jason Gotlib
Hematologist, Medical oncologist, Leukemia specialist, Hematologist-Oncologist
Professor of Medicine (Hematology)

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Cancer Clinical Trials Office