Clinical trial NCT00149162: Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2
Official title: Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Leukemia
Keywords: Controlled
Multicenter
International
Randomized study
Direct individual benefit
complete remission after chemotherapy
non allogeneic transplanted
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Chiron Corporation
First posted: 2005-09-08
Enrollment: 580
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
timeFrame: 1 year
Secondary outcomes:
measure: Analyze the whole toxicity of the regimen
timeFrame: 1 year
measure: Examine the prognostic biological factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Children Armand Trousseau Hospital
Study officials:
affiliation: Department of Pediatrics Hematology, Children Armand Trousseau Hospital, 26 Avenue Arnold Netter, 75012 Paris
name: Guy Leverger, M.D.
role: PRINCIPAL_INVESTIGATOR
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