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A Randomized, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

Trial Profile

A Randomized, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 30 Jun 2022

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At a glance

  • Drugs Decitabine (Primary) ; Cytarabine; Daunorubicin; Etoposide
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Sponsors Eisai Inc
  • Most Recent Events

    • 24 Jun 2022 Status changed from completed to discontinued.
    • 11 Dec 2018 A population pharmacokinetic model was developed by pooling decitabine concentration-time data from 5 adult (AML and MDS) and 2 pediatric (AML) studies (DACO-018, DACO-017, DACO-020, DACO-016, E7373-A001-101, E7373-G000-202 and DACOGENAML2004 trial); results published in the Journal of Clinical Pharmacology
    • 06 Mar 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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