Clinical trial · Observational
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
NCT01650467CI-TRIAL-00025751abl LMCwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding is late, unforseeable.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Chronic-Phase | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Healthy controls
- description
- 60 healthy controls with no hematological pathologies
- label
- Imatinib optimal response
- description
- 30 CML patients who are optimal responders to imatinib treatment
- label
- Imatinib primary resistance
- description
- 30 CML patients who have primary resistance to imatinib treatment
Primary outcomes (1)
- measure
- abl genotype
- timeFrame
- baseline ; at diagnosis
- description
- The abl genotype will be determined for all subjects
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.