Dettagli per singolo studio

DEC-NET Serial number FR322

Published online	30/09/2004 15.28.00
Last updated	27/11/2006 10.26.07

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	MYELOID LEUKEMIA CHRONIC
Experimental drug
mesylate Imatinib Treatment regimen (dosage and duration) 260-400 mg/m2/day for 2 years. If molecular remission (negative RT-PCR) duration is limited to 1 year.
Gender	Both
Age (range)	2 - 18 years
Eligibility criteria
Inclusion criteria
- Male or female patients <= 18 years of age. - Patients with a chronic myeloid leukaemia (CML)confirmed by the presence of the translocation t(9; 22)(q34; q11) or by the presence of BCR-ABL transript if the translocation t(9; 22)(q34; q11)is absent - Patient in chronic phase of a CML: less than 5% of blastes in bone marrow. less than 30% of blastes plus promyelocytes in the peripheral blood and bone marrow. peripheral basophilis => 20% Thrombocytes > 150 x 109/l - No extra-medullary involvement (except for a hepatomegaly and/or splenomegaly) - Absence of any previous treatment of the chronic myeloïd leukaemia except with hydroxyurea. - Stop of hydroxyurea at least 2 sweek before the beginning of mesylate imatinib. - Chronic phase of CML diagnosed in the previous 2 months - No cardiac, pulmonary, hepatic, renal or neurological disease with grade > 2 according to WHO classification - Contraceptive Method is used during all study in teenagers - Patient who can be followed regularly at least during 2 years. -Written voluntary informed consent of the parents
Exclusion criteria
- Patients with a Lansky Performance Score < 60. - Patient receiving another treatent under investigation in the 28 days preceding entry in the trial Patients with a cardiac disease grade 3 or 4 - Patients with a history of non-compliance or who are considered potentially unreliable Patients with any serious concomitant medical condition. - Prenancy and women of childbearing potential unless a safe contraception is used. Male or female patients not using contraception. - Patients who might benefit from a geno-identical stem cell transplantation within 3 months
Trial design/methodology
Phase	4
Kind of study	Efficacy Safety
Design
Purpose of study
To evaluate the rate of survival without progression in patients younger than 18 years with chronic myeloid leukaemia (CML) treated with Imatinib mesylate, who cannot benefit from a geno-identical stem cell transplantation.




Summary of study design, objectives, and ongoing research findings
The objective of the present open trial is to evaluate the rate of progression free survival of patients younger than 18 years with chronic myeloid leukaemia (CML), treated by Imatinib mesylate and who cannot benefit from a geno-identical stem cell transplantation. Imatinib treatment is administered at the daily dose of 260-400 mg/m2/ for 2 years. Tolerance is also evaluated.