A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients ≥65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy

Trial Profile

A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients ≥65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2017

At a glance

  • Drugs Volasertib (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms POLO-AML-2
  • Sponsors Boehringer Ingelheim Pharmaceuticals; Unilfarma
  • Most Recent Events

    • 03 Nov 2017 Planned End Date changed from 31 Dec 2018 to 31 Dec 2019.
    • 17 Oct 2017 Planned End Date changed from 31 Dec 2017 to 31 Dec 2018.
    • 14 Sep 2017 The study has been completed in Portugal.
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