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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
580
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
Children Armand Trousseau Hospital
Paris, France
RECRUITINGInterest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
Time frame: 1 year
Analyze the whole toxicity of the regimen
Time frame: 1 year
Examine the prognostic biological factors
Time frame: 1 year
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