Glivec in Pediatric Chronic Myeloid Leukemia (CML)

Poitiers University Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Imatinib mesylate 100 mg (Glivec)

Study type: Interventional

Funder types: Other

Identifiers

NCT00845221

GLIVEC PHASE IV

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

44 participants in 1 patient group

Imatinib

Experimental group

Treatment:

Drug: Imatinib mesylate 100 mg (Glivec)