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Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic-Phase

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Trial Information

Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms


The first secondary objective of this study is to identify, in patients not responding to
treatment, possible changes in the polymorphisms of interest during the course of the
disease, reclassifing such polymorphisms as mutations.

The second secondary objective is to compare the control patients in terms of polymorphism
frequency on the nonpatholgoical abl fraction.


Inclusion Criteria:



- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

Inclusion Criteria for all CML patients

- Patients diagnosed with CML

- Treatment with Imatinib in first-line monotherapy and this for at least 18 months

- RNA and / or cDNA used for diagnosis correctly stored in the biobank

Inclusion Criteria for CML patients already having undergone 28-24 months of followup

- RNA and / or cDNA used for diagnosis/follow-up correctly stored in the biobank

- Cytogenetic results are available

- Absence of ITK mutation for the primary resistance subgroup

- Validated compliance

Inclusion Criteria for the control population

- Absence of hematologic malignancy

Exclusion Criteria:

- The patient is participating in another study

- The patient is in an exclusion period determined by a previous study

- The patient is under judicial protection, under tutorship or curatorship

- The patient refuses to sign the consent

- It is impossible to correctly inform the patient

- The patient is pregnant, parturient, or breastfeeding

- The patient has a contraindication for a treatment used in this study

Exclusion Criteria for CML patients already having undergone 28-24 months of followup

- Known or suspected cause for resistance (dose reduced due to intolerance, digestive
disease responsible for malabsorption ...)

Exclusion Criteria for the control population

- History or suspicion of hemopathy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

abl genotype

Outcome Description:

The abl genotype will be determined for all subjects

Outcome Time Frame:

baseline ; at diagnosis

Safety Issue:

No

Principal Investigator

Jean-Baptiste Gaillard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

LOCAL/2012/JBG-02

NCT ID:

NCT01650467

Start Date:

September 2013

Completion Date:

September 2014

Related Keywords:

  • Leukemia, Myeloid, Chronic-Phase
  • abl polymorphisms
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

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