Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Registration Number
- NCT01650467
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method abl genotype baseline ; at diagnosis The abl genotype will be determined for all subjects
- Secondary Outcome Measures
Name Time Method abl genotype 12 months after diagnosis The abl genotype will be determined for all subjects
abl non-leucemic fraction genotype 12 months after diagnosis The abl non-leucemic fraction genotype will be determined for CML patients
bcr-abl leucemic fraction genotype baseline ; at diagnosis The bcr-able leucemic fraction genotype will be determined for CML patients
Trial Locations
- Locations (3)
Clinique du Parc
🇫🇷Castelnau Le Lez, France
CHU de Montpellier - Hôpital Saint-Eloi
🇫🇷Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 9, France