Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2
Conditions
Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Controlled, Multicenter, International, Randomized study, Direct individual benefit, complete remission after chemotherapy, non allogeneic transplanted
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: proleukin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 18 Years
Minimum Age: N/A
Gender: Both
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
Location
Children Armand Trousseau Hospital
Paris, France
Status: Recruiting
Contact: Anne Auvrignon, M.D. - 33 1 44 73 60 62 - anne.auvrignon@trs.aphp.fr
Start Date
March 2005
Completion Date
March 2012
Sponsors
Assistance Publique - Hôpitaux de Paris
Source
Assistance Publique - Hôpitaux de Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page