NCT00845221

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

7.3 years

First QC Date

February 16, 2009

Last Update Submit

October 10, 2016

Conditions

Chronic Myeloid Leukemia

Study Arms (1)

Imatinib

EXPERIMENTAL
Drug: Imatinib mesylate 100 mg (Glivec)

Interventions

Imatinib mesylate 100 mg (Glivec)DRUG

260 mg/m2/day tablets

Imatinib

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Amiens

Amiens, 80000, France

Location

Hôpital La Timone - CHU de Marseille

Marseille, 13385, France

Location

Hôpital de Brabois - CHU de Nancy

Vendoeuvre Les Nancy, 54511, France

Location

Related Publications (2)

  • Millot F, Guilhot J, Baruchel A, Petit A, Bertrand Y, Mazingue F, Lutz P, Verite C, Berthou C, Galambrun C, Sirvent N, Yakouben K, Schmitt C, Gandemer V, Reguerre Y, Couillault G, Mechinaud F, Cayuela JM. Impact of early molecular response in children with chronic myeloid leukemia treated in the French Glivec phase 4 study. Blood. 2014 Oct 9;124(15):2408-10. doi: 10.1182/blood-2014-05-578567. Epub 2014 Aug 28.

    PMID: 25170123DERIVED

  • Millot F, Baruchel A, Guilhot J, Petit A, Leblanc T, Bertrand Y, Mazingue F, Lutz P, Verite C, Berthou C, Galambrun C, Bernard F, Yacouben K, Bordigoni P, Edan C, Reguerre Y, Couillault G, Mechinaud F, Cayuela JM, Guilhot F. Imatinib is effective in children with previously untreated chronic myelogenous leukemia in early chronic phase: results of the French national phase IV trial. J Clin Oncol. 2011 Jul 10;29(20):2827-32. doi: 10.1200/JCO.2010.32.7114. Epub 2011 Jun 13.

    PMID: 21670449DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

July 1, 2004

Primary Completion

November 1, 2011

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(3)