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: 11 Jul 2017

At a glance

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

    • 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
    • 31 Jan 2017 According to a Pfizer media release, based on additional data from this trial and a meta-analysis of patient-level data from over 3,000 patients in five randomized Phase 3 studies company has completed regulatory submissions. The PDUFA goal date for a decision by the FDA is in September 2017.
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