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Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia.

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Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2022

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At a glance

  • Drugs Decitabine (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Eisai Inc

    • Most Recent Events

    • 03 Dec 2021 Results of a network meta-analysis of data from VIALE-A, VIALE-C, AZA-001, AZA-AML-001, and DACO-016 studies presented at the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 11 Dec 2018 A population pharmacokinetic model was developed by pooling decitabine concentration-time data from 5 adult (AML and MDS) and 2 pediatric (AML) studies (DACO-018, DACO-017, DACO-020, DACO-016, E7373-A001-101, E7373-G000-202 and DACOGENAML2004 trial); results published in the Journal of Clinical Pharmacology
    • 12 Dec 2017 Results of post-hoc analysis assessing disease burden reported by patients, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.

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