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Brief Title: Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
Official Title: Randomized Phase III Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
Study ID: NCT03897127
Brief Summary: The trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische Universität Graz, Graz, , Austria
Tirol Kliniken GmbH Innsbruck, Innsbruck, , Austria
Ordensklinikum Linz GmbH, Elisabethinen, Linz, , Austria
Feldkirch, Landeskrankenhaus, Rankweil, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Hanuschkrankenhaus Wien, Wien, , Austria
Klinikum Aschaffenburg, Aschaffenburg, , Germany
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Berlin Charite - Campus Charite Mitte, Berlin, , Germany
Vivantes Klinikum Am Urban, Berlin, , Germany
Berlin Charite - Campus Benjamin Franklin, Berlin, , Germany
Vivantes Klinikum Neukölln, Berlin, , Germany
Charité Berlin, Berlin, , Germany
Bochum, Augusta-Kranken-Anstalt, Bochum, , 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
St.-Johannes-Hospital, Dortmund, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Kliniken Essen Süd, Ev. Krankenhaus Essen- Werden gGmbH, Essen, , Germany
Klinikum Esslingen, Esslingen, , Germany
Malteser Krankenhaus St. Franziskus-Hospital, Flensburg, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Gießen, Gießen, , Germany
Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital gGmbH Goch, Goch, , Germany
Universitätsmedizin Greifswald, Greifswald, , Germany
Asklepios Kliniken Hamburg GmbH St. Georg, Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Evangelisches Krankenhaus Hamm gGmbH, Hamm, , Germany
Klinikum Region Hannover - Klinikum Siloah, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
SLK-Kliniken GmbH Heilbronn, Heilbronn, , Germany
Marienhospital Herne, Klinikum der Ruhr, Herne, , Germany
Kaiserslautern, Westpfalz-Klinikum, Kaiserslautern, , Germany
Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
Klinikum Lippe-Lemgo, Lemgo, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Klinikum Lüdenscheid, Lüdenscheid, , Germany
Universitätsklinikum Magdeburg, Magdeburg, , Germany
Klinikum der Johannes Gutenberg Universität, Mainz, , Germany
Klniikum Hochsauerland GmbH, Meschede, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Klinikum rechts der Isar München, München, , Germany
Sana Klinikum Offenbach, Offenbach, , Germany
Ortenau Klinikum, Offenburg-Gengenbach, Offenburg, , Germany
Pius Hospital Oldenburg, Oldenburg, , Germany
Klinikum Oldenburg gGmbH, Oldenburg, , Germany
Klinikum Passau, Passau, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Marienhaus Klinikum St. Elisabeth Saarlouis, Saarlouis, , Germany
Sande, Nordwest-Krankenhaus Sanderbusch, Sande, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Stuttgart, Diakonie-Klinikum, Stuttgart, , Germany
Klinikum Traunstein, Traunstein, , Germany
Mutterhaus der Borromäerinnen, Trier, , Germany
Krankenhaus der Barmherzigen Brüder Trier, Trier, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Schwarzwald-Baar Klinikum Villingen- Schwenningen GmbH, Villingen-Schwenningen, , Germany
Helios Klinikum Wuppertal, Wuppertal, , Germany