NCT00845221

Glivec in Pediatric Chronic Myeloid Leukemia (CML)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Imatinib mesylate 100 mg (Glivec)	260 mg/m2/day tablets

Timeline

• Start date: 2004-07-01
• Primary completion: 2011-11-01
• First posted: 2009-02-18
• Last updated: 2016-10-11

Locations

3 sites across 1 country: France