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

Study Overview
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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.

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.

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

Conditions
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Leukemia, Myeloid, Chronic-Phase

Participation Criteria
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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 Inclusion Criteria for all CML patients 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 Inclusion Criteria for CML patients already having undergone a follow-up visit at 12 months 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 optimal response group: bcr-abl typing is less than 0.1% at 12 months Inclusion criteria for the primary resistance group bcr-abl typings is >1% and/or Philadelphia+ is greater than 0 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 a follow-up visit at 12 months 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>60 healthy controls with no hematological pathologies | |
| Imatinib optimal response<br>30 CML patients who are optimal responders to imatinib treatment | |
| Imatinib primary resistance<br>30 CML patients who have primary resistance to imatinib treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abl genotype | The abl genotype will be determined for all subjects | baseline ; at diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abl genotype | The abl genotype will be determined for all subjects | 12 months after diagnosis | 
| bcr-abl leucemic fraction genotype | The bcr-able leucemic fraction genotype will be determined for CML patients | 12 months after diagnosis | 
| bcr-abl leucemic fraction genotype | The bcr-able leucemic fraction genotype will be determined for CML patients | baseline ; at diagnosis | 
| abl non-leucemic fraction genotype | The abl non-leucemic fraction genotype will be determined for CML patients | baseline ; at diagnosis | 
| abl non-leucemic fraction genotype | The abl non-leucemic fraction genotype will be determined for CML patients | 12 months after diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abl polymorphisms