NCT00210366终止2 期
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
International Extranodal Lymphoma Study Group (IELSG)2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- objective response to treatment
研究概览
简要总结
The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of non-Hodgkin's lymphoma
- •Disease exclusively localised into the CNS at first diagnosis and failure
- •Progressive or recurrent disease
- •Previous treatment with HDMTX containing CHT and/or RT
- •Presence of at least one target lesion, bidimensionally measurable
- •Age 18 - 75 years
- •ECOG performance status < 3 (Appendix 1).
- •No known HIV disease or immunodeficiency
- •HBsAg-negative and Ab anti-HCV-negative patients.
- •Adequate bone marrow function (plt > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3)
- •Adequate renal function (serum creatinine < 2 times UNL)
- •Adequate hepatic function (SGOT/SGPT < 3 times UNL, bilirubin and alkaline phosphatase < 2 times UNL)
- •Adequate cardiac function (VEF ≥ 50%)
- •Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
- •No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
- •No concurrent treatment with other experimental drugs.
- •Informed consent signed by the patient before registration
排除标准
- 未提供
结局指标
主要结局
objective response to treatment
次要结局
- duration of response
- overall survival
- acute side effects of idarubicin
研究者
研究点 (2)
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