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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Oral administration 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.
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
Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.
Time frame: 1 year
To determine the number of patients who have safety and tolerability events
Time frame: 1 year
To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments
Time frame: 1 year
To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003)
Time frame: 1 year
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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