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

Leukemia, Myeloid, Chronic-Phase Clinical Trial

— abl LMC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01650467
• Other study ID #: LOCAL/2012/JBG-02
• Secondary ID: 2012-A00639-34
• Status: Withdrawn
• Phase: N/A
• First received: July 24, 2012
• Last updated: January 31, 2017
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Locations

Country	Name	City	State
France	Clinique du Parc	Castelnau Le Lez
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abl genotype	The abl genotype will be determined for all subjects	baseline ; at diagnosis
Secondary	abl genotype	The abl genotype will be determined for all subjects	12 months after diagnosis
Secondary	bcr-abl leucemic fraction genotype	The bcr-able leucemic fraction genotype will be determined for CML patients	12 months after diagnosis
Secondary	bcr-abl leucemic fraction genotype	The bcr-able leucemic fraction genotype will be determined for CML patients	baseline ; at diagnosis
Secondary	abl non-leucemic fraction genotype	The abl non-leucemic fraction genotype will be determined for CML patients	baseline ; at diagnosis
Secondary	abl non-leucemic fraction genotype	The abl non-leucemic fraction genotype will be determined for CML patients	12 months after diagnosis