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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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2018

At a glance

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

    • 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.
    • 14 Sep 2015 Results (at 1-year follow-up)published in the Advances in Therapy.
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