Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia
NCT ID: NCT01826214
Last Updated: 2016-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2013-05-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDE225-400
Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and then after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
LDE225
LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.
LDE225-800
Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
LDE225
LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.
Interventions
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LDE225
LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.
Eligibility Criteria
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Inclusion Criteria
* Performance status of 0, 1 or 2 per WHO classification.
* Adequate renal and liver function.
* Adequate blood creatine kinase value (CK \< 1.5ULN)
Exclusion Criteria
* Patient for which immediate allogeneic stem cell transplantation is the treatment of choice.
* Pregnant or nursing (lactating) women.
* Active CNS leukemic involvement
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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Duke University Medical Center SC-5
Durham, North Carolina, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Yvoir, , Belgium
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Magdeburg, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Nijmegen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Bergen, , Norway
Novartis Investigative Site
Trondheim, , Norway
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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CLDE225X2203
Identifier Type: -
Identifier Source: org_study_id
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