Glivec in Pediatric Chronic Myeloid Leukemia (CML)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Imatinib

Group Type EXPERIMENTAL

Imatinib mesylate 100 mg (Glivec)

Intervention Type DRUG

260 mg/m2/day tablets

Interventions

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Imatinib mesylate 100 mg (Glivec)

260 mg/m2/day tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No