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


Phase 3
N/A
18 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Guy Leverger, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

France: Ministry of Health

Study ID:

P030441

NCT ID:

NCT00149162

Start Date:

March 2005

Completion Date:

March 2012

Related Keywords:

  • Leukemia
  • Controlled
  • Multicenter
  • International
  • Randomized study
  • Direct individual benefit
  • complete remission after chemotherapy
  • non allogeneic transplanted
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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