NCT06692803已完成不适用
Real-World Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia in Earlier Lines of Therapy (ABL-2022-03)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,043
- 试验地点
- 1
- 主要终点
- Treatment Patterns
研究概览
简要总结
This was a retrospective, non-interventional, observational cohort study using Optum's de-identified Clinformatics® Data Mart Database. Adult patients newly diagnosed with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) were identified using the Optum database and classified into the following cohorts:
- First treatment cohort: Patients newly diagnosed with CML who received first treatment with a TKI.
- Second treatment cohort: Patients from first treatment cohort with a subsequent line of therapy (i.e., second treatment) with a TKI.
The observation period spanned from the start of data availability (i.e., 01 January 2007) to the earliest of end of data (i.e., 30 June 2022), end of continuous health plan enrollment, or death (if available). The index date was defined as the first treatment initiation for the first treatment TKI cohort and as the second treatment initiation for the second treatment TKI cohort. The baseline period consisted of the 6 months prior to the index date. The follow-up period started on the index date and ended at the earliest of end of observation period or hematopoietic stem cell transplantation (HSCT).
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
- •Adult patients who initiated their first treatment with imatinib, dasatinib, nilotinib, or bosutinib (conditional on Food and Drug Administration (FDA) approval dates) with 6 months continuous health plan enrollment prior to the first prescription fill date.
- •Patients with 2 or more diagnoses for CML (adult as of the first diagnosis for CML).
- •Patients had index date on or after first CML diagnosis.
- •Patients had no diagnoses for CML remission/relapse prior to index date.
- •Patients had no gastrointestinal stomach tumor (GIST) or chronic myelomonocytic leukemia (CMML) at any time.
- •Patients had no medical claims associated with a clinical trial during the baseline period.
- •Patients had no hematopoietic stem cell transplantation (HSCT) during the baseline period.
- •Patients had no CML-related chemotherapy treatments for accelerated phase (AP)/blast crisis (BC) during the baseline period.
- •First treatment cohort:
- •Patients started first treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
- •Patients had no HSCT during the first treatment baseline period.
- •Patients had no CML-related chemotherapy treatment for AP/BC during the first treatment baseline period.
- •Second treatment cohort:
- •Patients started second treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
- •Patients had no HSCT from the first treatment baseline period up to second treatment initiation.
- •Patients had no CML-related chemotherapy treatment for AP/BC from the first treatment baseline period up to second treatment initiation.
排除标准
- 未提供
结局指标
主要结局
Treatment Patterns
时间窗: Up to approximately 10 years
Tyrosine kinase inhibitor (TKI) treatment management patterns in CML patients on first line or second line TKI were assessed.
次要结局
- Proportion of Days Covered (PDC)(Up to approximately 10 years)
- Number of Patients per PDC Category(Up to approximately 10 years)
- Time to Treatment Discontinuation(Up to approximately 10 years)
- Time to Treatment Switch(Up to approximately 10 years)
- Time to First Treatment Interruption(Up to approximately 10 years)
- Time to First Dose Reduction(Up to approximately 10 years)
- Rate of Treatment Discontinuation(Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4)
- Rate of Treatment Switching(Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4)
- Rate of Treatment Interruption(Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4)
- Rate of Dose Reduction(Months 1, 3, 6, 9, 12, 18, and years 2, 3, 4)
- Number of Patients With Non-optimal Treatment (NOPT)(Up to approximately 10 years)
- Number of Patients With NOPT by First Generation TKI(Up to approximately 10 years)
- Number of Patients With NOPT by Second Generation TKI(Up to approximately 10 years)
- All-cause Healthcare Resource Utilization (HRU) per Patient per Year in NOPT Patients Compared to Reference Subgroup(2 years)
- CML-related HRU per Patient per Year in NOPT Patients Compared to Reference Subgroup(2 years)
- All-cause Direct Healthcare Costs per Patient per Year in NOPT Patients Compared to Reference Subgroup(2 years)
- CML-related Direct Healthcare Costs per Patient per Year in NOPT Patients Compared to Reference Subgroup(2 years)
研究者
研究点 (1)
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