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Clinical trials for 2016-001643-39

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44294   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    1 result(s) found for: 2016-001643-39. Displaying page 1 of 1.
    EudraCT Number: 2016-001643-39 Sponsor Protocol Number: 2215-CL-0302 Start Date*: 2017-02-09
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy...
    Medical condition: Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) CZ (Completed) PL (Completed) PT (Completed) SE (Completed) GR (Completed) DK (Completed) HR (Completed) FR (Completed) IT (Completed)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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