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

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ClinicalTrials.gov Identifier: NCT01650467
Recruitment Status : Withdrawn (Funding is late, unforseeable.)
First Posted : July 26, 2012
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

July 24, 2012
July 26, 2012
February 1, 2017
December 2014
June 2017   (Final data collection date for primary outcome measure)
abl genotype [ Time Frame: baseline ; at diagnosis ]
The abl genotype will be determined for all subjects
Same as current
Complete list of historical versions of study NCT01650467 on ClinicalTrials.gov Archive Site
  • abl genotype [ Time Frame: 12 months after diagnosis ]
    The abl genotype will be determined for all subjects
  • bcr-abl leucemic fraction genotype [ Time Frame: 12 months after diagnosis ]
    The bcr-able leucemic fraction genotype will be determined for CML patients
  • bcr-abl leucemic fraction genotype [ Time Frame: baseline ; at diagnosis ]
    The bcr-able leucemic fraction genotype will be determined for CML patients
  • abl non-leucemic fraction genotype [ Time Frame: baseline ; at diagnosis ]
    The abl non-leucemic fraction genotype will be determined for CML patients
  • abl non-leucemic fraction genotype [ Time Frame: 12 months after diagnosis ]
    The abl non-leucemic fraction genotype will be determined for CML patients
  • abl genotype [ Time Frame: 18 months after diagnosis ]
    The abl genotype will be determined for all subjects
  • bcr-abl leucemic fraction genotype [ Time Frame: 18 months after diagnosis ]
    The bcr-able leucemic fraction genotype will be determined for CML patients
  • bcr-abl leucemic fraction genotype [ Time Frame: baseline ; at diagnosis ]
    The bcr-able leucemic fraction genotype will be determined for CML patients
  • abl non-leucemic fraction genotype [ Time Frame: baseline ; at diagnosis ]
    The abl non-leucemic fraction genotype will be determined for CML patients
  • abl non-leucemic fraction genotype [ Time Frame: 18 months after diagnosis ]
    The abl non-leucemic fraction genotype will be determined for CML patients
Not Provided
Not Provided
 
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Two 7 ml EDTA tubes for genotyping abl and bcr-abl polymorphisms
Non-Probability Sample
We will include 60 healthy controls (free of hematologic pathology, seen in genetic counseling) and stratify the recruitment of patients with CML among 30 patients with optimal imatinib response and 30 with primary resistance.
Leukemia, Myeloid, Chronic-Phase
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
120
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01650467
LOCAL/2012/JBG-02
2012-A00639-34 ( Other Identifier: RCB number )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Jean-Baptiste Gaillard, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
January 2017