Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

NCT00149162 | Unknown Phase 3 DMC

• 2 other identifiers: P030441AOM 03142
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Analyze the whole toxicity of the regimen

  1 year

• Examine the prognostic biological factors

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Patients treated by Proleukin

Drug: proleukin

2

NO INTERVENTION

Without Proleukin

Interventions

proleukin DRUG

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

Also known as: Proleukin = Interleukin II

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Chiron Corporation: collaborator

Study Sites (1)

Children Armand Trousseau Hospital

Paris, France

RECRUITING

Related Publications (19)

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  PMID: 1997853 BACKGROUND

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• Behar C, Suciu S, Benoit Y, Robert A, Vilmer E, Boutard P, Bertrand Y, Lutz P, Ferster A, Tokaji E, Manel AM, Solbu G, Otten J. Mitoxantrone-containing regimen for treatment of childhood acute leukemia (AML) and analysis of prognostic factors: results of the EORTC Children Leukemia Cooperative Study 58872. Med Pediatr Oncol. 1996 Mar;26(3):173-9. doi: 10.1002/(SICI)1096-911X(199603)26:33.0.CO;2-H.

  PMID: 8544799 BACKGROUND

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  PMID: 9504514 BACKGROUND

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  PMID: 10577848 BACKGROUND

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  PMID: 10193940 BACKGROUND

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  PMID: 11352963 BACKGROUND

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  PMID: 9260575 BACKGROUND

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  PMID: 1932739 BACKGROUND

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  PMID: 7919330 BACKGROUND

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  PMID: 3489494 BACKGROUND

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  PMID: 8445429 BACKGROUND

MeSH Terms

Conditions

Leukemia

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Guy Leverger, M.D.

  Department of Pediatrics Hematology, Children Armand Trousseau Hospital, 26 Avenue Arnold Netter, 75012 Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Leverger, M.D.

CONTACT

33 1 44 73 60 62; guy.leverger@trs.aphp.fr

Tabassome Simon, M.D., Ph.D.

CONTACT

33 1 49 28 22 02; urcest@chusa.jussieu.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2012
• Last Updated: February 12, 2009

Record last verified: 2009-02

Locations

FR (1)