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A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia

Trial Profile

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs Pevonedistat (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 10 Aug 2021 Status changed from active, no longer recruiting to completed.
    • 07 Aug 2021 This trial has been completed in Belgium, according to European Clinical Trials Database record.
    • 17 Jun 2021 Results of an exposure-efficacy pooled analysis from three clinical studies: NCT01814826, NCT02782468 and NCT02610777 assessing impact of Pevonedistat exposure on efficacy and safety presented at the 26th Congress of the European Haematology Association
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