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Clinical trials for 2014-002388-13

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   44259   clinical trials with a EudraCT protocol, of which   7345   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: 2014-002388-13. Displaying page 1 of 1.
    EudraCT Number: 2014-002388-13 Sponsor Protocol Number: AZA-JMML-001 Start Date*: 2015-02-20
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics, safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric subjec...
    Medical condition: newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10054439 Juvenile chronic myelomonocytic leukemia LLT
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023249 Juvenile chronic myelomonocytic leukaemia PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) IE (Completed) AT (Completed) CZ (Completed) BE (Completed) IT (Completed) SE (Completed) DK (Completed) NL (Completed) FR (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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