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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014