A phase 3, randomized, double-blind, multicenter study of proteinase 3 PR1 peptide mixed with montanide ISA-51 VG adjuvant [leukaemia vaccine] and administered with GM-CSF [granulocyte-macrophage colony-stimulating factor; sargramostim] in elderly patients with AML [acute myeloid leukaemia] in first complete remission or adults in second complete remission: a pivotal study.

Trial Profile

A phase 3, randomized, double-blind, multicenter study of proteinase 3 PR1 peptide mixed with montanide ISA-51 VG adjuvant [leukaemia vaccine] and administered with GM-CSF [granulocyte-macrophage colony-stimulating factor; sargramostim] in elderly patients with AML [acute myeloid leukaemia] in first complete remission or adults in second complete remission: a pivotal study.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jan 2010

At a glance

  • Drugs Montanide ISA-51; PR1 peptide vaccine; Sargramostim
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 26 Feb 2009 Status changed from recruiting to active, no longer recruiting, as reported by ClinicalTrials.gov.
    • 13 Nov 2007 Trial centres added.
    • 12 Jun 2007 New trial record.
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