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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01650467

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic-Phase

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

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Healthy controls 60 healthy controls with no hematological pathologies
Imatinib optimal response 30 CML patients who are optimal responders to imatinib treatment
Imatinib primary resistance 30 CML patients who have primary resistance to imatinib treatment

Outcome Measures

Primary Outcome Measures

abl genotype [baseline ; at diagnosis]
The abl genotype will be determined for all subjects

Secondary Outcome Measures

abl genotype [12 months after diagnosis]
The abl genotype will be determined for all subjects
bcr-abl leucemic fraction genotype [12 months after diagnosis]
The bcr-able 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
abl non-leucemic fraction genotype [baseline ; at diagnosis]
The abl non-leucemic fraction genotype will be determined for CML patients
abl non-leucemic fraction genotype [12 months after diagnosis]
The abl non-leucemic fraction genotype will be determined for CML patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique du Parc	Castelnau Le Lez	France	34170
2	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier	France	34295
3	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9	France	30029