NCT02836158招募中2 期
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma
Navy General Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).
详细描述
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).
排除标准
- •Involved sites other than the brain, meninges, CSF, or the eyes.
- •Age less than 18 years or greater than 75 years.
- •Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).
- •Known cause of immunosuppression (ie, HIV type I infection).
- •Any previous malignancy.
- •Creatinine clearance below 60 mL/min.
- •Heart insufficiency (NYHA IIIB or IV).
- •Uncontrolled infection.
- •Noncompensated active pulmonary or liver disease.
- •Previously treated for PCNSL, except by corticosteroids.
研究组 & 干预措施
R-IDARAM plus intrathecal chemotherapy
Experimental
Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy
干预措施: R-IDARAM plus intrathecal chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 year Overall survival
3 year Overall survival
次要结局
未报告次要终点
研究者
Liren Qian
Doctor
Navy General Hospital, Beijing
研究点 (1)
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