Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2 (Elam02)

February 11, 2009 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

580

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Children Armand Trousseau Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guy Leverger, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze the whole toxicity of the regimen
Time Frame: 1 year
1 year
Examine the prognostic biological factors
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Chiron Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030441
  • AOM 03142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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