Glivec in Pediatric Chronic Myeloid Leukemia (CML)
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.
Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.
Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.
Chronic Myeloid Leukemia
Drug: Imatinib mesylate 100 mg (Glivec)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845221
|Amiens, France, 80000|
|Hôpital La Timone - CHU de Marseille|
|Marseille, France, 13385|
|Hôpital de Brabois - CHU de Nancy|
|Vendoeuvre les Nancy, France, 54511|