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Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: proleukin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Guy Leverger, M.D., Principal Investigator, Affiliation: Department of Pediatrics Hematology, Children Armand Trousseau Hospital, 26 Avenue Arnold Netter, 75012 Paris

Overall contact:
Guy Leverger, M.D., Phone: 33 1 44 73 60 62, Email: guy.leverger@trs.aphp.fr


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)

Secondary outcome:

Analyze the whole toxicity of the regimen

Examine the prognostic biological factors

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.


Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.


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

Locations and Contacts

Guy Leverger, M.D., Phone: 33 1 44 73 60 62, Email: guy.leverger@trs.aphp.fr

Children Armand Trousseau Hospital, Paris, France; Recruiting
Anne Auvrignon, M.D., Phone: 33 1 44 73 60 62, Email: anne.auvrignon@trs.aphp.fr
Tabassome Simon, M.D., Ph.D., Phone: 33 1 49 28 22 02, Email: urcest@chusa.jussieu.fr
Guy Leverger, M.D., Principal Investigator
Additional Information

Related publications:

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Starting date: March 2005
Last updated: February 11, 2009

Page last updated: August 23, 2015

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