Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,494
- 试验地点
- 142
- 主要终点
- The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
研究概览
简要总结
The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
详细描述
Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below
- •18 years or older at time of of CP-CML diagnosis
- •a) Imatinib Cohorts
- •Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients
- •Patients who started their first-line Imatinib treatment on or after October 1, 2010
- •b) Dasatinib Cohort
- •Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
- •c) Nilotinib Cohort
- •Patients who started their first-line Nilotinib treatment after the drug was approved in this indication
- •Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)
- •Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)
排除标准
- •Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded
- •Discontinuation Criteria:
- •Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial
结局指标
主要结局
The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
时间窗: Every 6 months for a follow-up period of 5-years from study index date
Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
The rate of discontinuation and treatment changes after initial TKI treatment
时间窗: Every 6 months for a follow-up period of 5-years from study index date
Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)
The duration of initial TKI treatment
时间窗: 5-years from study index date
Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
The rate of Complete Cytogenetic Response
时间窗: 12 months
The adherence to treatment
时间窗: Every 6 months for a follow-up period of 5-years from study index date
Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
次要结局
- Impact of first-line treatment options on quality of life(Every 6 months)
- Resource utilization associated with CML management(Every 6 months)
- Non-hematologic side effects from treatment affecting patient quality of life and outcomes(Every 6 months)
- Patient satisfaction with CML treatment(Every 6 months)
- Patterns of disease monitoring as observed in a real-world setting(Every 6 months)