Last updated on December 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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Ortenau Klinikum

Offenburg, Germany
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PIUS Hospital

Oldenburg, Germany
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Schwarzwald-Baar Klinikum

Villingen Schwenningen, Germany
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HELIOS Klinikum

Wuppertal, Germany
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Recruitment Status: Open


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