NCT01650467撤回不适用
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Centre Hospitalier Universitaire de Nīmes3 个研究点 分布在 1 个国家开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- abl genotype
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
abl genotype
时间窗: baseline ; at diagnosis
The abl genotype will be determined for all subjects
次要结局
- bcr-abl leucemic fraction genotype(baseline ; at diagnosis)
- abl genotype(12 months after diagnosis)
- abl non-leucemic fraction genotype(12 months after diagnosis)
研究者
研究点 (3)
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