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A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Trial Profile

A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2022

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At a glance

  • Drugs Sapacitabine (Primary) ; Decitabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms SEAMLESS
  • Sponsors Cyclacel Pharmaceuticals
  • Most Recent Events

    • 23 Aug 2021 Results assessing the survival benefit and safety of decitabine administered in alternating cycles with sapacitabine versus decitabine monotherapy in elderly patients with newly diagnosed acute myeloid leukemia, published in the Cancer.
    • 27 Mar 2019 According to a Cyclacel Pharmaceuticals media release, based on stratified and exploratory subgroup analyses and following consultation with three European regulatory authorities regarding a potential approval pathway for sapacitabine the Company intends to submit a request for scientific advice to the Scientific Advice Working Party (SAWP) of the European Medicines Agency.
    • 14 May 2018 According to a Cyclacel Pharmaceuticals media release, the company is planning to conduct regulatory authority meetings in 2018.
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