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临床试验/NCT02845232
NCT02845232已完成不适用

Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
1
主要终点
Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival

研究概览

简要总结

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.

The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 70 years old
  • AML according to the World Health Organization (WHO) criteria (% of blasts ≥ 20% in bone marrow aspiration).
  • All FAB subtypes.
  • Any type of AML (de novo or secondary)
  • All participants to clinical trials gave their written informed consent

排除标准

  • Have an Eastern Cooperative Oncology Group (ECOG) score ≥2
  • Active uncontrolled infection

结局指标

主要结局

Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival

时间窗: From starting treatment to death from any cause (up to 21 months)

The cost-effectiveness of blood product transfusion was determined among initial treatment subgroups: patients receiving intensive chemotherapy, patients receiving low-intensity treatments, and patients treated only by BSC.

次要结局

  • Complete remission (CR) rate(Duration of study (Month 21))
  • Number of blood product transfusions per patient(Duration of study (Month 21))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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