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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-06-30

Brief Summary

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The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.

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Detailed Description

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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, reclassifying such polymorphisms as mutations.

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

Conditions

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Leukemia, Myeloid, Chronic-Phase

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy controls

60 healthy controls with no hematological pathologies

No interventions assigned to this group

Imatinib optimal response

30 CML patients who are optimal responders to imatinib treatment

No interventions assigned to this group

Imatinib primary resistance

30 CML patients who have primary resistance to imatinib treatment

No interventions assigned to this group

Eligibility Criteria

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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

* Patients diagnosed with CML
* Treatment with Imatinib in first-line monotherapy and this for at least 12 months
* RNA and / or cDNA used for diagnosis correctly stored in the biobank

* 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

* bcr-abl typing is less than 0.1% at 12 months

* bcr-abl typings is \>1% and/or Philadelphia+ is greater than 0

* 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

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

* History or suspicion of hemopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes