Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

Detailed Description
-----------------
We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Official Title
-----------------
Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: proleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 0 to 18 years Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts > 20 %) Isolated myeloid sarcoma Achieved complete remission No HLA identical family donor, except for the patients with t(8;21) No contraindication for the use of interleukin-2 Exclusion Criteria: Trisomy 21 Promyelocytic leukemia (M3) or M3 variations Secondary AML

Ages Eligible for Study
-----------------
Maximum Age: 18 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: 1<br>Patients treated by Proleukin | Drug: proleukin<br>* One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous) 1 cycle of treatment each month during 12 months<br>* Other names: Proleukin = Interleukin II;|
| No Intervention: 2<br>Without Proleukin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the whole toxicity of the regimen |  | 1 year | 
| Examine the prognostic biological factors |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Controlled, Multicenter, International, Randomized study, Direct individual benefit, complete remission after chemotherapy, non allogeneic transplanted