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: 01 Sep 2017

At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Pharmacogenomic; Therapeutic Use
  • Acronyms Mylofrance 3
  • 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.
    • 11 Jul 2017 According to a Pfizer media release, the U.S. FDA Oncologic Drug Advisory Committee (ODAC) voted that the results of this ALFA-0701 study demonstrated a favorable risk:benefit profile to chemotherapy for patients with newly-diagnosed acute myeloid leukemia (AML).
    • 10 Jun 2017 Biomarkers information updated
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