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

Study Overview
=================
Brief 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

Detailed Description
-----------------
Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.

Official Title
-----------------
Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: chemotherapy (Aracytine + Daunorubicin)
* Drug: chemotherapy (Aracytine + Daunorubicin)
* Drug: chemotherapy (Aracytine + Daunorubicin)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm1 = Aracytine + Daunorubicin<br>Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3 | Drug: chemotherapy (Aracytine + Daunorubicin)<br>* Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3<br>|
| Active Comparator: Arm 3 = Aracytine And Idarubicin<br>Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4 | Drug: chemotherapy (Aracytine + Daunorubicin)<br>* Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4<br>|
| Active Comparator: Arm 2 = Aracytine And Idarubicin<br>Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3 | Drug: chemotherapy (Aracytine + Daunorubicin)<br>* Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukemia in adults, Newly-diagnosed untreated AML, Patient aged 50 to 70 years