Glivec in Pediatric Chronic Myeloid Leukemia (CML)
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.