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Dose Finding Safety Run-in Phase Followed by a Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) Administered Prior or After Chemotherapy in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

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Dose Finding Safety Run-in Phase Followed by a Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) Administered Prior or After Chemotherapy in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Volasertib (Primary) ; Cytarabine; Daunorubicin; Mitoxantrone
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Therapeutic Use

    • Most Recent Events

    • 02 Dec 2016 Status changed from recruiting to discontinued.
    • 13 Apr 2016 Status changed from not yet recruiting to recruiting.
    • 02 Dec 2015 Planned number of patients changed from 352 to 264 as per ClinicalTrials.gov record.

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