Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
NCT ID: NCT00880269
Last Updated: 2017-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2009-08-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stratum A
patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
Panobinostat/LBH589
Stratum B
patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
Panobinostat/LBH589
Interventions
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Panobinostat/LBH589
Eligibility Criteria
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Inclusion Criteria
* Life expectancy of ≥ 60 days
* Eastern Cooperative Group (ECOG) performance status ≤ 2
* Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
* Negative serum pregnancy test (within 7 days of first dose)
* Negative urine pregnancy test immediately prior to first dose
Exclusion Criteria
* Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
* Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
* Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
* Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
* Patient unable to swallow capsules
* Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
Chicago, Illinois, United States
Nebraska Methodist Hospital Nebraska Methodist Hospital(2)
Omaha, Nebraska, United States
North Shore University Hospital North Shore Univ
Manhasset, New York, United States
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)
New York, New York, United States
Oregon Health Sciences University Dept. of OHSU (2)
Portland, Oregon, United States
University of Texas Southwestern Medical Center Dept of Simmons Cancer Center
Dallas, Texas, United States
University of Texas/MD Anderson Cancer Center Dept of MD Anderson (14)
Houston, Texas, United States
Novartis Investigative Site
Gosford, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
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Fitzroy, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Bruges, , Belgium
Novartis Investigative Site
Ghent, , Belgium
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Liège, , Belgium
Novartis Investigative Site
Bobigny, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Toulouse, , France
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Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Leipzig, , Germany
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Roma, RM, Italy
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Roma, RM, Italy
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Udine, UD, Italy
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Surquillo, Lima region, Peru
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Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Barcelona, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Zurich, Switzerland, Switzerland
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Balcova / Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Aberdeen, Scotland, United Kingdom
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2008-002983-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589B2213
Identifier Type: -
Identifier Source: org_study_id
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