Spots Global Cancer Trial Database for Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation
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Trial Identification
Brief Title: Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation
Official Title: Phase III Study of Chemotherapy in Combination With ATRA With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia and NPM1 Gene Mutation
Study ID: NCT00893399
Conditions
Study Description
Brief Summary: Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation. Before Amendment No. 4 (December 2013): Primary Efficacy Objective: * Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1) After Amendment No. 4 (December 2013): Primary Efficacy Objective: * Evaluation of efficacy based on overall survival (OS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Universitäts Graz, Graz, , Austria
Universitätsklinikum Innsbruck, Innsbruck, , Austria
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H., Linz, , Austria
Krankenhaus der Barmherzigen Schwestern Linz, Linz, , Austria
Krankenhaus der Elisabethinen Linz, Linz, , Austria
Salzburger Landeskliniken, Salzburg, , Austria
Hanuschkrankenhaus Wien, Wien, , Austria
Klinikum Aschaffenburg-Alzenau, Aschaffenburg, , Germany
Ubbo-Emmius-Klinik Aurich, Aurich, , Germany
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Vivantes Klinikum am Urban, Berlin, , Germany
Vivantes Klinikum Neukölln, Berlin, , Germany
Charité Berlin - Campus Virchow Klinikum, Berlin, , Germany
Knappschaftskrankenhaus Bochum-Langendreer, Bochum, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Klinikum Bremen-Mitte, Bremen, , Germany
Klinikum Darmstadt, Darmstadt, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH, Essen, , Germany
Klinikum Esslingen, Esslingen, , Germany
St. Franziskus Hospital, Flensburg, , Germany
Klinikum Frankfurt Höchst GmbH, Frankfurt-Höchst, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Medizinisches Versorgungszentrum Osthessen GmbH, Fulda, , Germany
Universitätsklinikum Gießen, Gießen, , Germany
Wilhelm-Anton-Hospital gGmbH Goch, Goch, , Germany
Universitätsklinikum Göttingen, Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Evangelisches Krankenhaus Hamm gGmbH, Hamm, , Germany
Klinikum Hanau, Hanau, , Germany
KRH Klinikum Hannover-Siloah, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK-Kliniken GmbH Heilbronn, Heilbronn, , Germany
Universitätskliniken des Saarlandes, Homburg, , Germany
Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
Universitätsklinikum Kiel, Kiel, , Germany
Caritas-Krankenhaus Lebach, Lebach, , Germany
Klinikum Lippe-Lemgo, Lemgo, , Germany
Klinikum Lüdenscheid, Lüdenscheid, , Germany
Universitätsklinikum der Otto-von Guericke Universität Magdeburg, Magdeburg, , Germany
Klinikum der Johannes Gutenberg Universität Mainz, Mainz, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Klinikum Schwabing, München, , Germany
Klinikum rechts der Isar München, München, , Germany
Lukaskrankenhaus GmbH Neuss, Neuss, , Germany
Ortenau Klinikum Offenburg Gengenbach, Offenburg, , Germany
Klinikum Oldenburg gGmbH, Oldenburg, , Germany
Klinikum Passau, Passau, , Germany
Caritas-Klinik St. Theresia Saarbrücken, Saarbrücken, , Germany
Stauferklinikum Schwäbisch Gmünd, Schwabisch Gmund, , Germany
Klinikum Stuttgart - Katharinenhospital, Stuttgart, , Germany
Diakonie-Klinikum Stuttgart, Stuttgart, , Germany
Klinikum Traunstein, Traunstein, , Germany
Krankenhaus der Barmherzigen Brüder, Trier, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen, , Germany
Helios Klinikum Wuppertal, Wuppertal, , Germany
Contact Details
Name: Hartmut Doehner, MD
Affiliation: University of Ulm
Role: PRINCIPAL_INVESTIGATOR
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