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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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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

    • 08 Jun 2021 Status changed from active, no longer recruiting to completed.
    • 21 May 2021 Planned number of patients changed from 660 to 770.
    • 26 Mar 2021 This trial is completed in France, according to European Clinical Trials Database record.

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