Dettagli per singolo studio

DEC-NET Serial number FR535

Published online	06/07/2006 15.19.00
Last updated	21/09/2006 13.02.32

Other protocol ID number	AOM 03142
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	MYELOID LEUKEMIA ACUTE
Experimental drug
ALDESLEUKIN Treatment regimen (dosage and duration) Subcutaneous or not administration of Interleukine 2: Day1: 2,5 million units/m² without exceeding 4 million. -Day2 to Day5: 5 million units/m²/d without exceeding 8 millions/injection
Gender	Both
Age (range)	0-18 years
Eligibility criteria
Inclusion criteria
Initial inclusion criterias : -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 Secondary inclusion criterias, before randomization : -Patient must have 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
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised
Purpose of study
Primary objective : To evaluate the interest of a 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 (event= relapse or toxic death) Secondary objectives : -To compare the results of allogeneic stem cell transplantation with those of chemotherapy -To compare the results of allogeneic stem cell transplantation with the results obtained by a maintenance treatment with interleukin-2 after the chemotherapy -To analyse the whole toxicity of this regimen -To identify biological factors associated with prognosis .
Primary outcomes
-Event free survival (event = relapse or death)the patients in persistant complete remission after induction/consolidation chemotherapy, treated with or without Interleukine 2
Secondary outcomes
-Percentage of complete remission -Event free survival (event= death or first relapse) of the all of the recorded patients -Total survival: survival of all the recorded patients -Event free survival of the allogeneic transplanted patients
Summary of study design, objectives, and ongoing research findings
Controlled, multicentre, international, randomized study of childhood an acute myeloid leukemia. Primary objective : To evaluate the interest of maintenance treatment with interleukin-2 by studying the event free survival (event=relapse or toxic death) of non allogenic transplanted children, in complete remission after induction and consolidation chemotherapy. Interleukin-2 is administered by a monthly regimen of 5 days during 1 year.