NCT00199108已完成2 期
A Phase-2 Clinical Study to Determine the Efficacy and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of CNS Relapse in Adult Patients With Acute Lymphoblastic Leukemia or Very Aggressive Lymphoma
Goethe University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- response rate after one application of DepoCyte
研究概览
简要总结
Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3 weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary objective is the response rate after one application of DepoCyte. Further objectives are the compilation of data regarding safety and toxicity
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
- 否
入选标准
- •proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse
- •CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan indicating the presence of meningeal involvement
- •in combined relapse in CNS and other locations: systemic therapy with CNS active drugs can be postponed for at least 2 weeks
- •Karnofsky Performance Score is > or = 60%
- •18 years of age or older
- •free of uncontrolled infection
- •recovered from any grade III / IV toxicities attributable to prior treatment with the exception of hematotoxicity
- •patient not pregnant or breast feeding and effective methods to prevent pregnancy
- •free from severe heart, lung, liver or kidney dysfunction
- •written informed consent
排除标准
- •failed to respond (as defined by no clearance of the CSF) to > 1 dose of prior i.th. MTX or ARAC or triple therapy
- •history of neurotoxicity (grade III - IV) attributed to i.th. or systemic HD therapy with MTX or ARAC
- •prior CNS relapse < 1 month before
研究组 & 干预措施
Only 1 arm
Experimental
干预措施: Depocyt (Drug)
Only 1 arm
Experimental
干预措施: Dexamethasone (Drug)
结局指标
主要结局
response rate after one application of DepoCyte
时间窗: one cycle
次要结局
- response rate at later time-points, toxicity (WHO), death in induction and CR, time to neurological progression, frequency of improvement in pre-existing meningeal-disease related neurological symptoms, Karnofsky Performance Status, Survival(after each cycle and during follow-up)
研究者
Nicola Goekbuget
Principal Investigator
Goethe University
研究点 (1)
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