NCT00684619已完成2 期
Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Goethe University11 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2003年6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
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
研究概览
简要总结
The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplantation.
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
- •T-ALL; T-NHL
- •age >= 18 years
- •cytological treatment failure / relapse
- •molecular treatment failure / relapse
- •no promising therapy alternatives with approved medication available
- •no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
- •no convulsive disease or neurotoxicity > grade III in patients history
- •written informed consent
- •no cytostatic therapy in the last 10 days
- •no pregnancy or breastfeeding
- •effective contraception
- •recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation
排除标准
- •Severe psychiatric illness
- •uncontrolled or severe cardiac disease or infection
- •active secondary neoplasms - except skin cancer (no melanoma)
研究组 & 干预措施
Arm A
Experimental
Nelarabine
干预措施: Nelarabine (Drug)
结局指标
主要结局
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
时间窗: after 1 cycle and 2 cycles
次要结局
未报告次要终点
研究者
Nicola Goekbuget
GMALL Head
Goethe University
研究点 (11)
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