NCT01650467WithdrawnNot Applicable
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Centre Hospitalier Universitaire de Nīmes3 sites in 1 countryStarted: December 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 3
- Primary Endpoint
- abl genotype
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
abl genotype
Time Frame: baseline ; at diagnosis
The abl genotype will be determined for all subjects
Secondary Outcomes
- abl genotype(12 months after diagnosis)
- abl non-leucemic fraction genotype(12 months after diagnosis)
- bcr-abl leucemic fraction genotype(baseline ; at diagnosis)
Investigators
Study Sites (3)
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