Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Last updated: February 11, 2009
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Trial Status Unknown

Phase

3

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT00149162
P030441
AOM 03142
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 showingmyelodysplasia (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

Exclusion Criteria:

  • Trisomy 21

  • Promyelocytic leukemia (M3) or M3 variations

  • Secondary AML

Study Design

Total Participants: 580
Study Start date:
March 01, 2005
Estimated Completion Date:
March 31, 2012

Study 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.

Connect with a study center

  • Children Armand Trousseau Hospital

    Paris,
    France

    Active - Recruiting

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