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

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

Conditions: Leukemia, Myeloid, Chronic-Phase

Study type: Observational

Funder types: Other

Identifiers

NCT01650467

2012-A00639-34 (Other Identifier)

LOCAL/2012/JBG-02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Healthy controls

Description:

60 healthy controls with no hematological pathologies

Imatinib optimal response

Description:

30 CML patients who are optimal responders to imatinib treatment

Imatinib primary resistance

Description:

30 CML patients who have primary resistance to imatinib treatment