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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chiron Corporation
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00149162
First received: September 6, 2005
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Leukemia
Drug: proleukin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Analyze the whole toxicity of the regimen [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Examine the prognostic biological factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 580
Study Start Date: March 2005
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Proleukin = Interleukin II
No Intervention: 2
Without Proleukin

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149162

Contacts
Contact: Guy Leverger, M.D. 33 1 44 73 60 62 guy.leverger@trs.aphp.fr
Contact: Tabassome Simon, M.D., Ph.D. 33 1 49 28 22 02 urcest@chusa.jussieu.fr

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

Publications:

Responsible Party: Therese Ngoue, Direction Interregionale de la Recherche Clinique, Ile de France, APHP
ClinicalTrials.gov Identifier: NCT00149162     History of Changes
Other Study ID Numbers: P030441, AOM 03142
Study First Received: September 6, 2005
Last Updated: February 11, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Controlled
Multicenter
International
Randomized study
Direct individual benefit
complete remission after chemotherapy
non allogeneic transplanted

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 15, 2014