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A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

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Trial Profile

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2023

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Busulfan; Cyclophosphamide; Cytarabine; Daunorubicin; Sargramostim
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use

Most Recent Events

  • 25 Apr 2023 Results NCT00046930 and NCT00049517 assessing whether obesity is associated with unique clinical and disease-related phenotypic features in AML and analyzing its influence on physician treatment decisions regarding daunorubicin dosing, published in the Cancer
  • 12 Sep 2019 Planned End Date changed from 1 Oct 2016 to 1 Dec 2019.
  • 04 Dec 2018 Results evaluating event-free survival (EFS) as a surrogate endpoint for OS in untreated AML from 4 multicenter, randomized controlled phase III trials (n=2475), NCT00085124, NCT00651261,NCT00085709, NCT00049517, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology

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