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Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS).

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Trial Profile

Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS).

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Aug 2012

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At a glance

  • Drugs Decitabine (Primary) ; Decitabine (Primary)
  • Indications Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 11 Mar 2010 Results from this trial were used to support US FDA approval of the 5-day decitabine regimen in patients with myelodysplastic syndromes, as reported by Eisai.
    • 09 Jun 2009 Actual patient number changed from 95 to 128 added as reported by ClinicalTrials.gov.
    • 09 Jun 2009 Actual end date (May 2009) added as reported by ClinicalTrials.gov.

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