Leukemia, Myeloid, Chronic-Phaseabl LMCNCT01650467
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
An observational study of Leukemia, Myeloid, Chronic-Phase, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase
- How many people
- 0 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Inclusion Criteria for CML patients already having undergone a follow-up visit at 12 months
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 ...)
- History or suspicion of hemopathy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique du Parc
Castelnau-le-Lez, 34170
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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.
Read the 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.
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Keywords
- abl polymorphisms
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
abl genotype
The abl genotype will be determined for all subjects
Measured: baseline ; at diagnosis
Secondary outcomes (5)
abl genotype
The abl genotype will be determined for all subjects
Measured: 12 months after diagnosis
bcr-abl leucemic fraction genotype
The bcr-able leucemic fraction genotype will be determined for CML patients
Measured: 12 months after diagnosis
bcr-abl leucemic fraction genotype
The bcr-able leucemic fraction genotype will be determined for CML patients
Measured: baseline ; at diagnosis
abl non-leucemic fraction genotype
The abl non-leucemic fraction genotype will be determined for CML patients
Measured: baseline ; at diagnosis
abl non-leucemic fraction genotype
The abl non-leucemic fraction genotype will be determined for CML patients
Measured: 12 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startDec 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Funding is late, unforseeable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, Chronic-PhaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Gaillard, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650467
- Sponsor's protocol ID
- LOCAL/2012/JBG-02
- Other IDs
- 2012-A00639-34
- Acronym
- abl LMC
- Status last verified
- Jan 2017
- First submitted
- 24 Jul 2012
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
- ClinicalTrials.gov ID
- NCT01650467
- Acronym / sponsor ID
- abl LMC / LOCAL/2012/JBG-02
- Conditions
- Leukemia, Myeloid, Chronic-Phase
- Keywords
- abl polymorphisms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding is late, unforseeable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
abl genotype
Time frame: baseline ; at diagnosis
The abl genotype will be determined for all subjects
5 secondary outcomes
abl genotype
Time frame: 12 months after diagnosis
bcr-abl leucemic fraction genotype
Time frame: 12 months after diagnosis
bcr-abl leucemic fraction genotype
Time frame: baseline ; at diagnosis
abl non-leucemic fraction genotype
Time frame: baseline ; at diagnosis
abl non-leucemic fraction genotype
Time frame: 12 months after diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Related trials for Leukemia, Myeloid, Chronic-Phase
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Gaillard, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Chronic-Phase, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abl genotype (time frame: baseline ; at diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.