A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
NCT ID: NCT01055483
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
59 participants
INTERVENTIONAL
2009-09-30
2012-02-29
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBH589
panobinostat/LBH589B
Interventions
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panobinostat/LBH589B
Eligibility Criteria
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Inclusion Criteria
* First relapsed AML
* Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
* Age more than 18 years
* ECOG performance status \< 2
Exclusion Criteria
* Concurrent therapy with any other investigational agent
* Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
* Clinical symptoms suggesting CNS leukemia
18 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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Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Ulm, , Germany
Countries
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Related Links
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Results for LBH589B2116 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2008-002986-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589B2116
Identifier Type: -
Identifier Source: org_study_id