A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged 50-70 Years Old.

Trial Profile

A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged 50-70 Years Old.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2018

At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Pharmacogenomic; Therapeutic Use
  • Acronyms Mylofrance 3
  • Most Recent Events

    • 23 Feb 2018 The European CHMP of the EMA has granted a positive opinion recommending marketing authorization of MYLOTARG (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia in the European Union. The MAA for MYLOTARG was based on data this trial.
    • 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.
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