Spots Global Cancer Trial Database for Protocol in Acute Myeloid Leukemia With FLT3-ITD
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Trial Identification
Brief Title: Protocol in Acute Myeloid Leukemia With FLT3-ITD
Official Title: Phase-II Study Evaluating Midostaurin in Induction, Consolidation and Maintenance Therapy Also After Allogeneic Blood Stem Cell Transplantation in Patients With Newly Diagnosed Acute Myeloid Leukemia Exhibiting a FLT3 Internal Tandem Duplication
Study ID: NCT01477606
Conditions
Study Description
Brief Summary: This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria. The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD. Sample size: 440 patients The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation \[chemotherapy or allogeneic SCT\], maintenance and follow-up period: Maximum 8 years
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Universität Innsbruck, Innsbruck, , Austria
Krankenhaus der Barmherzigen Schwestern Linz, Linz, , Austria
Krankenhaus der Elisabethinen Linz GmbH, Linz, , Austria
Universitätsklinik für Innere Medizin III Salzburg, Salzburg, , Austria
Hanuschkrankenhaus Wien, Wien, , Austria
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Vivantes Klinikum Neukölln, Berlin, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Marienhospital Bochum-Herne, Bochum, , Germany
Medizinische Universitätsklinik Bochum, Bochum, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Klinikum Bremen-Mitte gGmbH, Bremen, , Germany
Klinikum Darmstadt, Darmstadt, , Germany
Universitätsklinkum Düsseldorf, Düsseldorf, , Germany
Kliniken Essen-Süd, Essen, , Germany
Klinik für Onkologie, Gastroenterologie und Allg. Innere Medizin Esslingen, Esslingen, , Germany
Malteser Krankenhaus St. Franziskus Hospital Flensburg, Flensburg, , Germany
Medizinische Universitätsklinik Freiburg, Freiburg, , Germany
MVZ Osthessen, Fulda, , Germany
Klinik der Justus-Liebig-Universität Gießen, Gießen, , Germany
Wilhelm-Anton-Hospital gGmbH Goch, Goch, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
Universitätsklinikum Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Evangelisches Krankenhaus Hamm, Hamm, , Germany
Klinikum Region Hannover GmbH, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK Kliniken Heilbronn GmbH, Heilbronn, , Germany
Universitätskliniken des Saarlandes, Homburg/Saar, , Germany
Städtisches Klinikum Karlsruhe, Karlsruhe, , Germany
Städtisches Krankenhaus Kiel GmbH, Kiel, , Germany
Caritas Krankenhaus Lebach, Lebach, , Germany
Klinikum Lippe-Lemgo, Lemgo, , Germany
Märkische Kliniken GmbH Lüdenscheid, Lüdenscheid, , Germany
Universitätsklinikum der Otto-von-Guericke Universität Magdeburg, Magdeburg, , Germany
Universitätsklinikum der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Stauferklinikum Mutlangen, Mutlangen, , Germany
Klinikum Schwabing, München, , Germany
Klinikum rechts der Isar der TU München, München, , Germany
Ortenau Klinikum, Offenburg, , Germany
Pius Hospital Oldenburg, Oldenburg, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Klinikum Passau, Passau, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Caritasklinik St. Theresia Saarbrücken, Saarbrücken, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Diakonie-Klinikum Stuttgart, Stuttgart, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH Trier, Trier, , Germany
Krankenhaus der Barmherzigen Brüder Trier, Trier, , Germany
Medizinische Universitätsklinik Tübingen, Tübingen, , Germany
University Hospital of Ulm, Ulm, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen, , Germany
Helios Klinikum Wuppertal, Wuppertal, , Germany
Contact Details
Name: Hartmut Doehner, MD
Affiliation: University Hospital of Ulm
Role: PRINCIPAL_INVESTIGATOR
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