Spots Global Cancer Trial Database for Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
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)
Study ID: NCT01242774
Conditions
Interventions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Hannover, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain
Novartis Investigative Site, Barcelona, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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