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Glivec in Pediatric Chronic Myeloid Leukemia (CML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845221
First Posted: February 18, 2009
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Poitiers University Hospital
  Purpose

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.


Condition Intervention Phase
Chronic Myeloid Leukemia Drug: Imatinib mesylate 100 mg (Glivec) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Enrollment: 44
Study Start Date: July 2004
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Drug: Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845221


Locations
France
CHU Amiens
Amiens, France, 80000
Hôpital La Timone - CHU de Marseille
Marseille, France, 13385
Hôpital de Brabois - CHU de Nancy
Vendoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Docteur Frédéric MILLOT/principal investigator, CHU DE POITIERS
ClinicalTrials.gov Identifier: NCT00845221     History of Changes
Other Study ID Numbers: GLIVEC PHASE IV
First Submitted: February 16, 2009
First Posted: February 18, 2009
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action