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临床试验/NCT01724294
NCT01724294终止不适用

Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP

Hoffmann-La Roche0 个研究点目标入组 113 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
113
主要终点
Treatment patterns in clinical practice: Number of treatment cycles received

研究概览

简要总结

This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.

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

入选标准

  • Adult patients, >18 years of age
  • Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP

排除标准

  • Prior chemotherapy treatment for diffuse large B-cell lymphoma
  • Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan

结局指标

主要结局

Treatment patterns in clinical practice: Number of treatment cycles received

时间窗: approximately 4 years

次要结局

  • Response rates(approximately 4 years)
  • Safety: Incidence of adverse events(approximately 4 years)
  • Event-free survival(approximately 4 years)

研究者

申办方类型
Industry
责任方
Sponsor

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