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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.

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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.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 03 Nov 2021

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At a glance

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

    • Most Recent Events

    • 23 Feb 2018 Results assessing Gemtuzumab ozogamicin as mono-therapy and combination therapy in ALFA-0701 and AML19 for FDA 2017 approval of gemtuzumab ozogamicin, published in the Clinical cancer research: an official journal of the American Association for Cancer Research
    • 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
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