A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

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 of 50-70 Years Old.

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

Patients with a morphologically proven diagnosis AML and both the two following criteria:

• Age > 50 years and £ 70 years.
• Not previously treated for their disease.

Randomization will be centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Inclusion Criteria:

• Patients with a morphologically proven diagnosis AML and both the two following criteria: Age > 50 years and £ 70 years. Not previously treated for their disease.
• ECOG performance status 0 to 3
• Negative serology HIV, HBV and HBC (except post vaccination)
• Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N
• Cardiac function determined by radionucleide or echography within normal limits.
• Negative serum pregnancy test within one week before treatment for women of child bearing potential.
• Signed informed consent.

Exclusion Criteria:

• M3-AML
• AML following previously know myeloproliferative syndrome.
• Known central nervous system involvement.
• Uncontrolled infection
• Other active malignancy