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临床试验/NCT00072449
NCT00072449终止2 期

A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins18 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
12
试验地点
18
主要终点
Radiographic Response

研究概览

简要总结

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.

详细描述

OBJECTIVES:

Primary

  • Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.

Secondary

  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Radiographic Response

时间窗: 1 month, 2 months and then q3months

it at any time point patient progresses no more scans are required, patient is off study

次要结局

  • Progression-free Survival(pt had MRI q3months)
  • Overall Survival(47 months)
  • Toxicity(8 weeks - 2 cycles)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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