A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator's choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

Trial Profile

A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator's choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1)

Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Volasertib (Primary) ; Antineoplastics; Azacitidine; Clofarabine; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms POLO-AML-1
  • Most Recent Events

    • 29 Sep 2012 Planned end date (16 Feb 2013) added as reported by European Clinical Trials Database record.
    • 04 Aug 2012 Actual initiation date changed from 22 Aug 2011 to 16 Jun 2011 as reported by European Clinical Trials Database.
    • 30 Jun 2012 Actual initiation date changed from 26 Jul 2011 to 22 Aug 2011 as reported by European Clinical Trials Database.
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