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

A

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

  • Trisomy 21
  • Promyelocytic leukemia (M3) or M3 variations
  • Secondary AML

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

580 participants in 2 patient groups

1
Active Comparator group
Description:
Patients treated by Proleukin
Treatment:
Drug: proleukin
2
No Intervention group
Description:
Without Proleukin

Trial contacts and locations

1

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Central trial contact

Tabassome Simon, M.D., Ph.D.; Guy Leverger, M.D.

Data sourced from clinicaltrials.gov

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