Elam02: Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT00149162

Collaborator

Chiron Corporation (Industry)

580

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: proleukin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

580 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Patients treated by Proleukin	Drug: proleukin 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 Other Names: Proleukin = Interleukin II
No Intervention: 2 Without Proleukin

Arm

Intervention/Treatment

Active Comparator: 1

Patients treated by Proleukin

Drug: proleukin

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

Other Names:

Proleukin = Interleukin II

No Intervention: 2

Without Proleukin

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Analyze the whole toxicity of the regimen [1 year]
Examine the prognostic biological factors [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children Armand Trousseau Hospital	Paris		France

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
Chiron Corporation

Investigators

Principal Investigator: Guy Leverger, M.D., Department of Pediatrics Hematology, Children Armand Trousseau Hospital, 26 Avenue Arnold Netter, 75012 Paris