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A Randomized, Multicenter, Open-label, Phase 2 Study, With a Safety Run-in Part to Evaluate Safety, Pharmacodynamics and Efficacy of Azacitidine Compared to No Anticancer Treatment in Children and Young Adults With Acute Myeloid Leukemia in Molecular Relapse After First Complete Remission

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Trial Profile

A Randomized, Multicenter, Open-label, Phase 2 Study, With a Safety Run-in Part to Evaluate Safety, Pharmacodynamics and Efficacy of Azacitidine Compared to No Anticancer Treatment in Children and Young Adults With Acute Myeloid Leukemia in Molecular Relapse After First Complete Remission

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Dec 2021

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At a glance

  • Drugs Azacitidine (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Celgene Corporation

    • Most Recent Events

    • 08 Dec 2021 The randomized part of the study was not conducted. The study is continuing as an investigator-sponsored study to further explore efficacy of AZA in AML with molecular relapse in children and young adults as per the results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
    • 08 Dec 2020 Results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 19 Dec 2019 Status changed from active, no longer recruiting to completed.
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