NCT00085150已完成1 期
Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
研究概览
简要总结
RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug, including the terminal elimination serum half-life, area under the curve, volume of distribution, and relationship to disease burden, in these patients.
Secondary
- Evaluate the immonogenicity of this drug in these patients.
- Determine response in patients treated with this drug.
- Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
研究点 (10)
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