Spots Global Cancer Trial Database for Efficacy and Safety of Midostaurin in Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia
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Trial Identification
Brief Title: Efficacy and Safety of Midostaurin in Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia
Official Title: A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease
Study ID: NCT00782067
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California at Los Angeles Dept. of Hematology Clinic, Los Angeles, California, United States
Stanford University Medical Center Stanford University 2, Stanford, California, United States
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia, Augusta, Georgia, United States
Dana Farber Cancer Institute Hematology / Oncology, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(3), Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2), New York, New York, United States
Oregon Health and Science University Dept. Hematologic Malignancies, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Virginia Commonwealth University SC, Richmond, Virginia, United States
Novartis Investigative Site, Camperdown, New South Wales, Australia
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, London, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Amiens, , France
Novartis Investigative Site, Paris cedex 15, , France
Novartis Investigative Site, Mannheim, Baden-Württemberg, Germany
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Gdansk, , Poland
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Glasgow - Scotland, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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