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

Not Recruiting

Trial ID: NCT01242774


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)

Stanford Investigator(s)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Jason Gotlib

Professor of Medicine (Hematology)


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


drug: panobinostat

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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