Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 主要终点
- Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
研究概览
简要总结
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
详细描述
Historic cohort prolonged by a 12-month follow-up period.
Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.
Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.
The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with CP-CML. (ACA) are allowed
- •Age >18 years old
- •Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
- •Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.
排除标准
- •Patients in (or with history of) accelerated or blastic phase CML
- •Patients treated by allogeneic stem cell transplantation.
- •Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
- •Patients treated with 2G TKI for reasons other than imatinib failure.
- •Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
- •Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.
研究组 & 干预措施
Patients in CP-CML treated with 2G TKI
Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure
干预措施: Imatinib (Drug)
结局指标
主要结局
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
时间窗: CCyR at 6 month of 2GTKI treatment
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following: * Distribution of patients according to Hammersmith score levels * Characterization of association between Hammersmith score and occurrence of CCyR * Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods. This score is measured at the time of imatinib failure.
次要结局
- Predictive value of Hammersmith score compared to other factors(From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death)
- Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs(For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010))
- Predictive value of Hammersmith score on Major Molecular Response (MMR)(MMR at 3 month of 2GTKI treatment)
- Predictive factors of Overall survival (including Hammersmith score, MMR at 3 months and CCyR at 6 months of 2G TKI treatment together with patients, disease and treatment characteristics)(From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death)
- Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI(When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009)