NCT00210340撤回1 期
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis
International Extranodal Lymphoma Study Group (IELSG)0 个研究点开始时间: 2005年9月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Safety profile of rituximab given intrathecally
研究概览
简要总结
The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
- •Pathologically diagnosed CD20-positive NHL
- •Age ≥ 18 years
- •ECOG Performance Status 0 - 2 (See Appendix A)
- •Life expectancy of at least 1 month
- •Informed consent must be given according to national/local regulations before enrollment (See Appendix B)
- •Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or thiotepa for treatment of lymphomatous meningitis but these treatments must have completed at least two weeks before the study enrollment and the patients must have recovered from any reversible toxicity caused by prior treatments
- •Concurrent systemic chemotherapy is allowed with the exception of high-dose methotrexate (>500 mg/m2/day), high-dose cytarabine (>2 g/m2/day), high-dose thiotepa (>300 mg/m2/day) or investigational agents
- •No concurrent intrathecal chemotherapy other than rituximab
- •No severe impairment of bone marrow function (ANC >1.5x109/L, PLT >50x109/L), unless due to proven lymphoma involvement
- •No major impairment of renal function (serum creatinine < 1,5 x upper normal) or liver function (ASAT/ALAT < 2,5 upper normal, total bilirubin <2,5x upper normal), unless due to proven lymphoma involvement
- •No evidence of active opportunistic infections
- •No HIV infection
- •No pregnant or lactating status
- •Appropriate contraceptive method in women of childbearing potential or men
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.
排除标准
- 未提供
结局指标
主要结局
Safety profile of rituximab given intrathecally
次要结局
- collection of CSF samples devoted to ancillary biological studies
- preliminary evaluation of the antitumor activity of i.t. rituximab
- pharmacokinetics of different dose levels of intrathecal rituximab
研究者
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