Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
- Registration Number
- NCT01242774
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Panobinostat Panobinostat -
- Primary Outcome Measures
Name Time Method Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. 1 year
- Secondary Outcome Measures
Name Time Method To determine the number of patients who have safety and tolerability events 1 year To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) 1 year To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments 1 year
Trial Locations
- Locations (6)
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, 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
Stanford University Medical Center Stanford U
🇺🇸Stanford, California, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
🇺🇸Columbus, Ohio, United States
Novartis Investigative Site
🇪🇸Barcelona, Spain