Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149162

Acronym

Elam02

Enrollment

580

Registered

2005-09-08

Start date

2005-03-31

Completion date

2012-03-31

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

Controlled, Multicenter, International, Randomized study, Direct individual benefit, complete remission after chemotherapy, non allogeneic transplanted

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.

Interventions

DRUGproleukin

One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous) 1 cycle of treatment each month during 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)	1 year

Secondary

Measure	Time frame
Analyze the whole toxicity of the regimen	1 year
Examine the prognostic biological factors	1 year

Countries

France

Contacts

Primary ContactGuy Leverger, M.D.

guy.leverger@trs.aphp.fr33 1 44 73 60 62

Backup ContactTabassome Simon, M.D., Ph.D.

urcest@chusa.jussieu.fr33 1 49 28 22 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026