NCT01164696已完成不适用
A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 主要终点
- The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
研究概览
简要总结
The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Advanced cancer of the lymph nodes of follicular type at study inclusion
- •The patient has relapsed or has refractory disease, after previous treatment with rituximab
- •Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
- •The patient is >= 18 years of age
- •Patient has given informed consent
排除标准
- •Patient is unwilling or unable to give informed consent
- •Patient is participating in another clinical trial
研究组 & 干预措施
Group 1
干预措施: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) (Drug)
结局指标
主要结局
The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
时间窗: one year after inclusion
次要结局
- the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)(baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline)
- the clinical outcomes (survival status, response status), TTNT (time to next treatment)(1 year)
研究者
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