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 Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia Before Hematopoietic Stem Cell Transplantation

Trial Profile

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 Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia Before Hematopoietic Stem Cell Transplantation

Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Mar 2017

At a glance

  • Drugs Azacitidine (Primary)
  • Indications Juvenile myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 28 Feb 2017 Planned End Date changed from 1 Oct 2020 to 27 Sep 2022.
    • 28 Feb 2017 Planned primary completion date changed from 1 Sep 2018 to 15 Oct 2018.
    • 21 Apr 2016 Planned primary completion date changed from 1 Oct 2017 to 1 Sep 2018.
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