Glivec in Pediatric Chronic Myeloid Leukemia (CML)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Poitiers University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00845221
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Enrollment: 44
Study Start Date: July 2004
Estimated Study Completion Date: December 2011
Arms Assigned Interventions
Experimental: Imatinib Drug: Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Docteur Frédéric MILLOT/principal investigator, CHU DE POITIERS
ClinicalTrials.gov Identifier: NCT00845221     History of Changes
Other Study ID Numbers: GLIVEC PHASE IV
Study First Received: February 16, 2009
Last Updated: February 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014