Glivec in Pediatric Chronic Myeloid Leukemia (CML)

October 10, 2016 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU Amiens
      • Marseille, France, 13385
        • Hôpital La Timone - CHU de Marseille
      • Vendoeuvre les Nancy, France, 54511
        • Hôpital de Brabois - CHU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Imatinib
Drug: Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIVEC PHASE IV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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