NCT02414022进行中（未招募）不适用
Prospective Economic Analysis: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib + Rituximab vs Ibrutinib Alone in Untreated Older Patients (≥65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 19
- 主要终点
- Measure cost-utility ratio
研究概览
简要总结
The prospective cost-effectiveness (cost-utility) analysis from the perspective of the Canadian public healthcare system was completed in 2021. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tarrifs applied to calculate quality-adjusted life-years (QALYs). Costs were applied to resource utilization data (expressed in 20196 US dollars). We examined costs and outcomes (QALYs) associated with ibrutinib with rituximab (IR) and BR therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be eligible for the core CLC.2/A041202 protocol.
- •Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- •Patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. However, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol.
- •Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
排除标准
- 未提供
结局指标
主要结局
Measure cost-utility ratio
时间窗: 5 years
, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.
次要结局
- Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL(5 years)
- Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-rituximab compared to ibrutinib alone in elderly patients with CLL(5 years)
- Measure the incremental cost-effectiveness, as measured in cost per life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL(5 years)
- Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-alone compared to bendamustine-rituximab in elderly patients with CLL(5 years)
研究者
研究点 (19)
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