Last updated on May 2018

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel )


Brief description of study

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML

Detailed Study Description

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML; in the investigational arm, consolidation therapy is followed by a one-year maintenance therapy with dasatinib. Patients with molecular disease persistence or molecular relapse as assessed by quantitative RQ-PCR for the CBF fusion transcripts will be eligible for hematopoietic stem cell transplantation before overt hematologic relapse occurs. Primary endpoint is event-free survival.

AML patients will be assessed for the CBF fusion genes in one of two AMLSG central laboratories within 48 hours of diagnosis, and only patients with CBF-AML will be enrolled.

Clinical Study Identifier: NCT02013648

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David Nachbaur, Prof. Dr.

Universit tsklinik f r Innere Medizin V
Innsbruck, Austria
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Gregor Aschauer, Dr.

Krankenhaus der Barmherzigen Schwestern
Linz, Austria
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Sigrid Machherndl-Spandl, Dr.

Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria
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Richard Greil, Prof.

Universit tsklinik der PMU
Salzburg, Austria
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Elisabeth Koller, Dr.

Hanuschkrankenhaus
Wien, Austria
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Andrea Distelrath, Dr.

MVZ Osthessen
Fulda, Germany
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Heinz-August Horst, Prof. Dr.

Universit tsklinikum Schleswig-Holstein
Kiel, Germany
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Ulrich Bitz, Dr. med.

Helios Klinikum Bad Saarow, Klinik f r H matologie
Bad Saarow, Germany
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Christian Scholz, PD Dr.

Klinikum am Urban
Berlin, Germany
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Maike de Wit, Prof. Dr.

Klinikum Neuk lln
Berlin, Germany
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Jörg Westermann, PD Dr.

Charit Universit tsmedizin Campus Virchow Klinikum
Berlin, Germany
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Karin Mayer, Dr. med.

Universit tsklinikum Medizinische Klinik und Poliklinik III
Bonn, Germany
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Jürgen Krauter, Prof. Dr.

St dtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
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Bernd Hertenstein, Prof. Dr.

Klinikum Bremen Mitte gGmbH
Bremen, Germany
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Helga Bernhard, Prof. Dr.

Klinikum Darmstadt Medizinische Klinik V
Darmstadt, Germany
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Carsten Schwänen, PD Dr.

Klinikum Esslingen
Esslingen, Germany
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Nadezda Basara, Prof. Dr.

Malteser Krankenhaus St. Franziskus-Hospital
Flensburg, Germany
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Michael Lübbert, Prof. Dr.

Universit tsklinikum Freiburg
Freiburg, Germany
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Volker Runde, Prof. Dr.

Wilhelm-Anton-Hospital gGmbH
Goch, Germany
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Walter Fiedler, Prof. Dr.

Universit tsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Andrea Sendler, Dr.

Klinikum Hanau GmbH
Hanau, Germany
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Hartmut Kirchner, PD Dr.

Klinikum Region Hannover GmbH
Hannover, Germany
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Michael Heuser, PD Dr.

Medizinische Hochschule Hannover
Hannover, Germany
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Uwe Martens, Prof. Dr.

SLK-Kliniken GmbH
Heilbronn, Germany
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Beate Schultheis, Dr.

Marienhospital Klinikum der Ruhr-Universit t
Herne, Germany
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Mark Ringhoffer, PD Dr.

St dtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany
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Stephan Kremers, Dr.

Gemeinschaftspraxis H mato-Onkologie im Caritas Krankenhaus
Lebach, Germany
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Tanja Hesse

Klinikum Lippe GmbH
Lemgo, Germany
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Thomas Heinicke, Dr.

Univ-Klinikum der Otto-von Guericke-Universit t
Magdeburg, Germany
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Markus Radsak, PD Dr.

III. Medizinische Klinik und Poliklinik Universit tsmedizin der Johannes Gutenberg-Universit t
Mainz, Germany
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Hans-Joachim Tischler, Dr.

Johannes Wesling Klinikum
Minden, Germany
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Holger Hebart, Prof. Dr.

Stauferklinikum Schw bisch Gm nd
Mutlangen, Germany
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Andreas Jakob, Dr.

Ortenau Klinikum
Offenburg, Germany
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Frank Griesinger, Prof. Dr.

PIUS Hospital
Oldenburg, Germany
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Doris Krämer, Prof. Dr.

Klinikum Oldenburg gGmbH
Oldenburg, Germany
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Thomas Südhoff, Prof. Dr.

Klinikum Passau
Passau, Germany
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Jan Schleicher, Dr.

Klinikum Stuttgart
Stuttgart, Germany
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Claudio Denzlinger, Prof. Dr.

Vinzenz von Paul Kliniken gGmbH Marienhospital
Stuttgart, Germany
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Rolf Mahlberg, Dr.

Klinikum Mutterhaus der Borrom erinnen gGmbH
Trier, Germany
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Hartmut Döhner, Prof. Dr.

Universit tsklinikum Ulm Zentrum f r Innere Medizin
Ulm, Germany
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Wolfram Brugger, Prof.

Schwarzwald-Baar Klinikum
Villingen Schwenningen, Germany
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Mohammed Wattad

Kliniken Essen S d
Werden, Germany
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Silke Schostok, Dr.

HELIOS Klinikum
Wuppertal, Germany
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Ulrich Germing, Prof. Dr.

Universit tsklinikum Medizinische Klinik und Poliklinik
Düsseldorf, Germany
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Gerald Wulf, Prof. Dr.

Universit tsmedizin G ttingen
Göttingen, Germany
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Gerhard Heil, Prof. Dr.

M rkische Kliniken GmbH
Lüdenscheid, Germany
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Katharina Götze, PD Dr.

Klinikum rechts der Isar der TU
München, Germany
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Axel Matzdorff, Prof. Dr.

Caritasklinkum Saarbr cken St. Theresia
Saarbrücken, Germany
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Helmut Salih, Prof. Dr.

Medizinische Universit tsklinik
Tübingen, Germany
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