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: 17 Jun 2018

At a glance

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

    • 17 Jun 2018 Results presented at the 23rd Congress of the European Haematology Association
    • 23 Apr 2018 Based on the data from this trial, the European Commission has approved 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 (AML), except acute promyelocytic leukemia (APL).
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top