Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2 (Elam02)

Assistance Publique - Hôpitaux de Paris

Status and phase

Unknown

Phase 3

Conditions

Leukemia

Treatments

Drug: proleukin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00149162

AOM 03142

P030441

Details and patient eligibility

About

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.

Full 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.

Enrollment

580 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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