Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Chiron Corporation
• Treatments: Aldesleukin; Interleukin-2

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