Clinical trial NCT01650467: Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Official title: Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Leukemia, Myeloid, Chronic-Phase
Keywords: abl polymorphisms
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include 60 healthy controls (free of hematologic pathology, seen in genetic counseling) and stratify the recruitment of patients with CML among 30 patients with optimal imatinib response and 30 with primary resistance.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: abl genotype
timeFrame: baseline ; at diagnosis
Secondary outcomes:
measure: abl genotype
timeFrame: 12 months after diagnosis
measure: bcr-abl leucemic fraction genotype
timeFrame: 12 months after diagnosis
measure: bcr-abl leucemic fraction genotype
timeFrame: baseline ; at diagnosis
measure: abl non-leucemic fraction genotype
timeFrame: baseline ; at diagnosis
measure: abl non-leucemic fraction genotype
timeFrame: 12 months after diagnosis
Other outcomes:
Locations:
city: Castelnau Le Lez
country: France
facility: Clinique du Parc
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Baptiste Gaillard, MD
role: PRINCIPAL_INVESTIGATOR
References: