Udvidet adgangsprogram for AMN107 til Imatinib-resistente eller intolerante voksne patienter med kronisk myeloid leukæmi
En åben-label, multicenter, udvidet adgangsundersøgelse af oral AMN107 hos voksne patienter med imatinib-resistent eller intolerant kronisk myeloid leukæmi i blast krise, accelereret fase eller kronisk fase.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Saint Leonards, Australien
- Novartis Investigative Site
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Aalst, Belgien
- Novartis Investigative Site
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Antwerpen, Belgien
- Novartis Investigative Site
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Arlon, Belgien
- Novartis Investigative Site
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Brugge, Belgien
- Novartis Investigative Site
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Brussels, Belgien
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Bruxelles, Belgien
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Edegem, Belgien
- Novartis Investigative Site
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Gent, Belgien
- Novartis Investigative Site
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Hasselt, Belgien
- Novartis Investigative Site
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La Louviere, Belgien
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Leuven, Belgien
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Liege, Belgien
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Roeselare, Belgien
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Verviers, Belgien
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Yvoir, Belgien
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Belo Horizonte, Brasilien
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Brasilia-DF, Brasilien
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Campinas, Brasilien
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Curitaba, Brasilien
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Curitiba, Brasilien
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Porto Alegre-RS, Brasilien
- Novartis Investigative Site
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Ribeirao Preto, Brasilien
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Rio de Janeiro, Brasilien
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Sao Paulo, Brasilien
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Edmonton, Canada
- Novartis Investigative Site
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Halifax, Canada
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Hamilton, Canada
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Montreal, Canada
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Ottawa, Canada
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Toronto, Canada
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Vancouver, Canada
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Copenhagen, Danmark
- Novartis Investigative Site
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Vejle, Danmark
- Novartis Investigative Site
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Chelyabinsk, Den Russiske Føderation
- Novartis Investigative Site
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Moscow, Den Russiske Føderation
- Novartis Investigative Site
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Novosibirsk, Den Russiske Føderation
- Novartis Investigative Site
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Saint-Petersburg, Den Russiske Føderation
- Novartis Investigative Site
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Samara, Den Russiske Føderation
- Novartis Investigative Site
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Ufa, Den Russiske Føderation
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Cambridge, Det Forenede Kongerige
- Novartis Investigative Site
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Leeds, Det Forenede Kongerige
- Novartis Investigative Site
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Liverpool, Det Forenede Kongerige
- Novartis Investigative Site
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London, Det Forenede Kongerige
- Novartis Investigative Site
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Manchester, Det Forenede Kongerige
- Novartis Investigative Site
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Nottingham, Det Forenede Kongerige
- Novartis Investigative Site
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Alabama
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Mobile, Alabama, Forenede Stater, 36693
- University of South Alabama Cancer Research Institute
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope National Medical Center
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Lancaster, California, Forenede Stater, 93534
- Antelope Valley Cancer Center
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Palo Alto, California, Forenede Stater, 94304
- Stanford University
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Colorado
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Aurora, Colorado, Forenede Stater, 80010
- University of Colorado
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Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Cancer Center
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Washington Cancer Institute
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Washington, District of Columbia, Forenede Stater, 20007-2113
- Georgetown University Medical Center-Lombardi Cancer Center
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Florida
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Melbourne, Florida, Forenede Stater, 32901
- Osler Medical Inc./Osler Clinical Research
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Miami, Florida, Forenede Stater, 33176
- Advanced Medical Specialties
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Orange Park, Florida, Forenede Stater, 32073
- Integrated Community
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Orlando, Florida, Forenede Stater, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Forenede Stater, 32806
- MD Anderson Cancer Center
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Pensacola, Florida, Forenede Stater, 32501
- Hematology Oncology Assoc.
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Cancer Institute
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Augusta, Georgia, Forenede Stater, 30912
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Hospital
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Chicago, Illinois, Forenede Stater, 60612
- Stroger Cook County Hospital
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital & Health Centers
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals & Clinics
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Louisville Oncology Research
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71103
- LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21229
- St. Agnes Hospital
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University
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Grosse Pointe, Michigan, Forenede Stater, 48236
- St. John Hospital and Medical Center
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Hospital
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68516
- Southeast Nebraska Cancer Center
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Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Cancer Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89135
- Nevada Cancer Institute
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Health Sciences Center
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Santa Fe, New Mexico, Forenede Stater, 87505
- Cancer Institute of New Mexico
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
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Mineola, New York, Forenede Stater, 11501
- Winthrop Hematology/Oncology
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New York, New York, Forenede Stater, 10029
- Mount Sinai Medical Center
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New York, New York, Forenede Stater, 10021
- Weill Cornell Medical Center
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New York, New York, Forenede Stater, 10017
- Memorial Sloan Kettering Cancer Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University
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Winston Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 734112
- Cancer Care Associates
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Tulsa, Oklahoma, Forenede Stater, 74136
- Cancer Care Associates
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health Sciences University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Cancer Institute
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Charleston Hematology Oncology
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Charleston, South Carolina, Forenede Stater, 29425
- MUSC Hollings Cancer Center
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Columbia, South Carolina, Forenede Stater, 29203
- Three Medical Park
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Greenville, South Carolina, Forenede Stater, 29615
- Cancer Center Of The Carolinas
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- The Jones Clinic
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute
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Angers, Frankrig
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Bordeaux, Frankrig
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Caen, Frankrig
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Clermont-Ferrand, Frankrig
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Creteil, Frankrig
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Dijon, Frankrig
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Grenoble, Frankrig
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Le Chesnay, Frankrig
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Lille, Frankrig
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Limoges, Frankrig
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Lyon, Frankrig
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Marseille, Frankrig
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Nantes, Frankrig
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Nice, Frankrig
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Paris, Frankrig
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Poitiers, Frankrig
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Reims, Frankrig
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Rennes, Frankrig
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Rouen, Frankrig
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Strasbourg, Frankrig
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Toulouse, Frankrig
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Vandoeuvre, Frankrig
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Vandoeuvre les Nancy, Frankrig
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Athens, Grækenland
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Amsterdam, Holland
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Enschede, Holland
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Leiden, Holland
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Maastricht, Holland
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Rotterdam, Holland
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Pokfulam, Hong Kong
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Dublin, Irland
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Ancona, Italien
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Bari, Italien
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Bologna, Italien
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Bolzano, Italien
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Brescia, Italien
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Cagliari, Italien
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Campobasso, Italien
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Catania, Italien
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Catanzaro, Italien
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Ferrara, Italien
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Firenze, Italien
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Genova, Italien
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Milano, Italien
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Monza, Italien
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Napoli, Italien
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Novara, Italien
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Nuoro, Italien
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Orbassano, Italien
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Padova, Italien
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Palermo, Italien
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Pavia, Italien
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Perugia, Italien
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Pesaro, Italien
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Pescara, Italien
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Pisa, Italien
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Reggio Calabria, Italien
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Reggio Emilia, Italien
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Rionero in Vulture, Italien
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Roma, Italien
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Ronciglione, Italien
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San Giovanni Rotundo, Italien
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Siena, Italien
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Tarante, Italien
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Torino, Italien
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Udine, Italien
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Via Pansini, Italien
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Ankara, Kalkun
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Istanbul, Kalkun
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Malatya, Kalkun
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Samsun, Kalkun
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Beijing, Kina
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Guangzhou, Kina
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Shanghai, Kina
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Tianjing, Kina
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Daegu, Korea, Republikken
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Deajeon, Korea, Republikken
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Jeollanam-do, Korea, Republikken
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Pusan, Korea, Republikken
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Seoul, Korea, Republikken
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Beirut, Libanon
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Georgetown, Penang, Malaysia
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Kuala Lumpur, Malaysia
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Pulau Pinang, Malaysia
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Subang Jaya, Selangor, Malaysia
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Mexico D.F., Mexico
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Oslo, Norge
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Gdansk, Polen
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Krakow, Polen
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Poznan, Polen
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Szczecin, Polen
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Warszawa, Polen
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Basel, Schweiz
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Bern, Schweiz
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Lausanne, Schweiz
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Zurich, Schweiz
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Singapore, Singapore
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Bratislava, Slovakiet
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Kosice, Slovakiet
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Baracaldo, Pais Vasco, Spanien
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Barcelona, Cataluna, Spanien
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Cataluna, Spanien
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Granada, Andalucia, Spanien
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Las Palmas de Gran Canaria, Spanien
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Madrid, Spanien
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Malaga, Spanien
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Murcia, Spanien
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Salamanca, Castilla y Leon, Spanien
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San Sabastian, Pais Vasco, Spanien
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Santiago de Compostela, Spanien
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Valencia, Spanien
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Zaragoza, Spanien
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Goteborg, Sverige
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Linkoping, Sverige
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Lund, Sverige
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Stockholm, Sverige
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Uppsala, Sverige
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Cape Town, Sydafrika
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Johannesburg, Sydafrika
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Roodepoort, Gauteng, Sydafrika
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Chiayi, Taiwan
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Kaohsiung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Brno, Tjekkiet
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Hradec Kralove, Tjekkiet
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Olomouc, Tjekkiet
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Plzen-Lochotin, Tjekkiet
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Praha 2, Tjekkiet
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Aschaffenburg, Tyskland
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Augsburg, Tyskland
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Berlin, Tyskland
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Braunschweig, Tyskland
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Bremen, Tyskland
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Bremerhaven, Tyskland
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Chemnitz, Tyskland
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Dresden, Tyskland
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Essen, Tyskland
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Frankfurt, Tyskland
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Freiburg, Tyskland
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Greifswald, Tyskland
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Hamburg, Tyskland
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Hannover, Tyskland
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Heidelberg, Tyskland
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Kiel, Tyskland
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Koln, Tyskland
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Leipzig, Tyskland
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Mainz, Tyskland
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Mannheim, Tyskland
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Marburg, Tyskland
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Munchen, Tyskland
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Oldenburg, Tyskland
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Osnabruck, Tyskland
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Regensburg, Tyskland
- Novartis Investigative Site
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Stuttgart, Tyskland
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Tubingen, Tyskland
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Ulm, Tyskland
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Weiden, Tyskland
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Wiesbaden, Tyskland
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Budapest, Ungarn
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Graz, Østrig
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Innsbruck, Østrig
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Linz, Østrig
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Wels, Østrig
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Wien, Østrig
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Imatinib-resistent eller -intolerant Philadelphia kromosom-positiv kronisk myeloid leukæmi i blast krise, accelereret fase eller kronisk fase.
- Patienter med kronisk myeloid leukæmi, der er blevet behandlet med en tyrosinkinasehæmmer til undersøgelse.
- Laboratorieværdier inden for normale grænser.
Eksklusionskriterier:
- Nedsat hjertefunktion.
- Akut eller kronisk lever- eller nyresygdom anses for ikke at være relateret til tumor.
- Andre samtidige alvorlige og/eller ukontrollerede medicinske tilstande (f.eks. ukontrolleret diabetes, aktiv eller ukontrolleret infektion), der kan forårsage uacceptable sikkerhedsrisici eller kompromittere overholdelse af protokollen.
- Patienter, der i øjeblikket modtager behandling med nogen af de lægemidler, der har potentiale til at forlænge QT-intervallet eller hæmme metabolismen af AMN107 (CYP3A4/5-hæmmere).
- Patienter med en anamnese med en anden malignitet, som i øjeblikket er klinisk signifikant eller i øjeblikket kræver aktiv intervention.
Andre protokoldefinerede inklusions-/udelukkelseskriterier kan være gældende.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CAMN107A2109
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .