Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
NCT ID: NCT01242774
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2010-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Panobinostat
Panobinostat
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.
Interventions
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Panobinostat
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* = 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.
Exclusion Criteria
* 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
18 Years
65 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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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
Countries
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References
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DeAngelo DJ, Walker AR, Schlenk RF, Sierra J, Medeiros BC, Ocio EM, Rollig C, Strickland SA, Thol F, Valera SZ, Dasgupta K, Berkowitz N, Stuart RK. Safety and efficacy of oral panobinostat plus chemotherapy in patients aged 65 years or younger with high-risk acute myeloid leukemia. Leuk Res. 2019 Oct;85:106197. doi: 10.1016/j.leukres.2019.106197. Epub 2019 Aug 1.
Related Links
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Results for CLBH589G2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2009-016809-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589G2101
Identifier Type: -
Identifier Source: org_study_id