Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

Trial Profile

Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia

Suspended
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Decitabine (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 05 Jul 2017 Planned End Date changed from 1 Dec 2019 to 18 Sep 2017.
    • 01 Jul 2016 Status changed from recruiting to suspended as Dacogen (Decitabine) is unlikely to provide significant clinical benefit. Recruitment hold while discussions ongoing with PDCO.
    • 30 Jun 2016 This trial is suspended in Denmark.
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