Glivec in Pediatric Chronic Myeloid Leukemia (CML)

Chronic Myeloid Leukemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845221
• Other study ID #: GLIVEC PHASE IV
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2009
• Last updated: October 10, 2016
• Start date: July 2004

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Hôpital La Timone - CHU de Marseille	Marseille
France	Hôpital de Brabois - CHU de Nancy	Vendoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France,