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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT01242774

Run by

Novartis Pharmaceuticals

People needed

46

Starts

2010-10-01

Expected to finish

2014-05-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center Stanford U — Stanford, California, United States
• Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital — Columbus, Ohio, United States
• Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2) — Charleston, South Carolina, United States
• Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3 — Nashville, Tennessee, United States
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Salamanca, Castille and León, Spain
• Novartis Investigative Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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