Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

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

Details

• Lead Sponsor: Acute Leukemia French Association
• Collaborator: Assistance Publique - Hôpitaux de Paris
• Treatments: Cytarabine; Daunorubicin; Idarubicin

Criteria

Inclusion Criteria:

• Patient from 50 to 70 years

• AML de Novo

• No prior therapy for AML

• Absence of severe infection (WHO grade greater than 2), independent of the AML

• Cardiac function determined by radionucleotide or echography within normal limits.

• total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N

• ECOG performance status 0 to 3

• Signed informed consent.

Exclusion Criteria:

• M3-AML

• history of neoplasia treated by radiotherapy or chemotherapy

• Myelodysplasia diagnosed more than 6 months before the diagnosis of AML

• Prior treatment for AML

• Uncontrolled infection

• Other active malignancy

• Patient unable to undergo regular surveillance