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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acute Leukemia French Association
• Collaborator: Versailles Hospital
• Treatments: Cytarabine; Daunorubicin; Gemtuzumab

Criteria

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