Glivec in Pediatric Chronic Myeloid Leukemia (CML)
|ClinicalTrials.gov Identifier: NCT00845221|
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : October 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Imatinib mesylate 100 mg (Glivec)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2004|
|Primary Completion Date :||November 2011|
Drug: Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845221
|Amiens, France, 80000|
|Hôpital La Timone - CHU de Marseille|
|Marseille, France, 13385|
|Hôpital de Brabois - CHU de Nancy|
|Vendoeuvre les Nancy, France, 54511|