NCT01650467

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

July 24, 2012

Last Update Submit

January 31, 2017

Conditions

Leukemia, Myeloid, Chronic-Phase

Keywords

abl polymorphisms

Outcome Measures

Primary Outcomes (1)

  • abl genotype

    The abl genotype will be determined for all subjects

    baseline ; at diagnosis

Secondary Outcomes (5)

  • abl genotype

    12 months after diagnosis

  • bcr-abl leucemic fraction genotype

    12 months after diagnosis

  • bcr-abl leucemic fraction genotype

    baseline ; at diagnosis

  • abl non-leucemic fraction genotype

    baseline ; at diagnosis

  • abl non-leucemic fraction genotype

    12 months after diagnosis

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • 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
  • 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
  • bcr-abl typing is less than 0.1% at 12 months
  • bcr-abl typings is \>1% and/or Philadelphia+ is greater than 0
  • Absence of hematologic malignancy

You may not qualify if:

  • The patient is participating in another 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
  • Known or suspected cause for resistance (dose reduced due to intolerance, digestive disease responsible for malabsorption ...)
  • History or suspicion of hemopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinique du Parc

Castelnau-le-Lez, 34170, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two 7 ml EDTA tubes for genotyping abl and bcr-abl polymorphisms

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Baptiste Gaillard, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(3)