Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- assessment of efficacy, safety, pharmacokinetics, immunogenicity.
研究概览
简要总结
RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the immunogenicity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia.
- Determine the therapeutic efficacy of this drug in inducing remissions in these patients.
- 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
- 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
- 6 Months 至 24 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
研究组 & 干预措施
2
antibody therapy
干预措施: antibody-drug conjugate therapy (Procedure)
1
BL22 immunotoxin
干预措施: BL22 immunotoxin (Drug)
3
immunotoxin therapy
干预措施: immunotoxin therapy (Procedure)
4
monoclonal antibody therapy
干预措施: monoclonal antibody therapy (Procedure)
结局指标
主要结局
assessment of efficacy, safety, pharmacokinetics, immunogenicity.
时间窗: end of study
次要结局
- Expansion of MTD(end of study)