Gemtuzumab ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19) of the EORTC-LG and GIMEMA-ALWP.

Trial Profile

Gemtuzumab ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19) of the EORTC-LG and GIMEMA-ALWP.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Sep 2017

At a glance

  • Drugs Gemtuzumab ozogamicin (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Most Recent Events

    • 01 Sep 2017 According to a Pfizer media release, the US FDA approved MYLOTARG (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML. The approval of MYLOTARG was based on several investigator-led clinical trials, including ALFA-0701, AML-19 and MyloFrance-1.
    • 25 Jan 2016 Final results of the phase III part of the study published in the Journal of Clinical Oncology
    • 08 Dec 2014 Primary endpoint for phase III (Overall survival) has been met according to the abstract presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
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