Status:
COMPLETED
Glivec in Pediatric Chronic Myeloid Leukemia (CML)
Lead Sponsor:
Poitiers University Hospital
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- Old \< 18 years, male or female.
- Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11).
- Chronic phase of a chronic myeloid leukaemia
- Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly).
- Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea.
- Stop of hydroxyurea at least week before the beginning of the imatinib mesylate.
- Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months).
- Score of Lansky ≥ 60.
- Effective contraception among patients in age to procreate.
- Written voluntary informed consent of the two parents or the legal guardian.
Exclusion
- Patients with grade 3 / 4 cardiac disease.
- Pathology cardiac, pulmonary, hepatic, renal or neurological of grade \> 2 (WHO).
- Participation in a clinical trial in the 28 days preceding the beginning by the treatment.
- Impossible Follow-up during at least 2 years, patient not compliant.
- Expectant mother or nursing.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00845221
Start Date
July 1 2004
Last Update
October 11 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Amiens
Amiens, France, 80000
2
Hôpital La Timone - CHU de Marseille
Marseille, France, 13385
3
Hôpital de Brabois - CHU de Nancy
Vendoeuvre Les Nancy, France, 54511