Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors Among Chronic Myeloid Leukemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,769
- 试验地点
- 1
- 主要终点
- Quan-Charlson Comorbidity Index Score
研究概览
简要总结
The aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant's condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. No new data will be collected from participants as part of this study and no study medicines will be provided in this study.
详细描述
This is a retrospective cohort analysis study in participants with chronic phase chronic myeloid leukemia (CP-CML). This study will use Humedica electronic medical record (EMR) data to evaluate the real-world treatment patterns, safety, and efficacy of ponatinib and other tyrosine kinase inhibitors (TKIs) among CP-CML participants.
The study will enroll approximately 1769 patients. Based on the TKI drug used on index date, stratified by prior TKI use, participants will be classified into the following cohorts -
- Ponatinib Cohort
- Bosutinib Cohort
- Other TKI Cohort
This is a multicenter study conducted in the United States (US). The overall duration for data collection in this trial will be approximately 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quan-Charlson Comorbidity Index Score
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity.
Number of Participants with Bone Marrow Stem Cell Transplant
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of CML Participants With Baseline Clinical Characteristics of Disease Severity
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis
时间窗: Baseline (Day 1)
Socio-demographic variables included will include categories of Age (in years), Sex (male and female), and US geographic region.
Number of CML Participants With Baseline Clinical Characteristics of Comorbidities
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Comorbidities will include anemia, diabetes, chronic pulmonary disease, congestive heart failure, hypertension, hypercholesterolemia, obesity, renal disease, moderate to severe liver disease, dementia, acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV).
Number of CML Participants With Baseline Clinical Characteristics of Concomitant Medication
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Concomitant medication will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta blockers and statins) and antidiabetic drugs (metformin, sulfonylurea, thiazolidinedione, insulin and other antidiabetic drugs).
Number of Previous Treatments of Tyrosine Kinase Inhibitors (TKI) Drugs in Participants with CML
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
The number of TKI drugs used prior to the index date will be identified. The type of the 1\^st and 2\^nd TKI drugs will be identified.
Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs)
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as pulmonary embolism (PE) and deep vein thrombosis (DVT).
Duration Between Last TKI Run-out Date to the Index Date for Participants with CML
时间窗: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Time from the run-out date of the last prescription to the index date will be calculated. If the run-out date passed the index date, the gap will be counted as 0.
Treatment Patterns Based on Duration of Index Treatment
时间窗: Up to approximately 5 years
Time from the first prescription of the index drug to the run-out date of the last prescription of the index drug, or 1 day before a new TKI prescription date, whichever occurred earlier.
次要结局
- Percentage of CML Participants With Complications(Up to approximately 5 years)
- Progression Free Survival (PFS)(Up to approximately 5 years)
- Number of Participants With BCR-ABL and Bone Marrow Testing(Up to approximately 5 years)
- Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21(Up to approximately 5 years)
- Number of Participants With CML With Treatment-Free Gap of the Index Treatment(Up to approximately 5 years)
- Treatment Patterns Based on Number of Participants With CML on Concomitant Medication(Up to approximately 5 years)
- Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Disease Progression(Up to approximately 5 years)
- Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs)(Up to approximately 5 years)