Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
Guy Leverger, M.D.
Department of Pediatrics Hematology, Children Armand Trousseau Hospital, 26 Avenue Arnold Netter, 75012 Paris
France: Ministry of Health