Phase I Study in RAD 001 Patients With Relapse AML

Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission

A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.

Inclusion Criteria:

• patients from 18 to 65 years old
• AML in relapse more than 1 year after CR
• inform consent signed

Exclusion Criteria:

• age more than 65
• cardiac insufficiency
• renal insufficiency
• hepatic disease
• other type of AML
• blastic MCL
• HIV positive serology
• other malignancy
• pulmonary infection