A Phase I Study of Combination Therapy With Anti-CD19 and Anti-CD22 Immunotoxins (Combotox) in Adults With Refractory/Relapse Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
研究概览
简要总结
RATIONALE: Immunotoxins, such as anti-CD19 and anti-CD22, can find cancer cells that express CD19 and CD22 and kill them without harming normal cells. This may be an effective treatment for B-cell acute lymphoblastic leukemia.
PURPOSE: This phase I trial is studying the side effects and best dose of anti-CD19 and anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox) in patients with refractory or relapsed B-cell acute lymphoblastic leukemia.
- Determine the toxicity of Combotox in these patients.
- Determine the pharmacokinetic (PK) profile of Combotox in these patients.
- Determine any antitumor activity of Combotox, in terms of the percentage of blasts in bone marrow and peripheral blood.
- Determine the levels of human antimouse and human anti-dgA antibodies in patients treated with Combotox.
- Determine if there is a correlation between PK parameters and toxicity of Combotox in these patients.
- Determine if the expression of the CD19 and CD22 cell surface antigens is affected by Combotox.
OUTLINE: This is a dose-escalation study.
Patients receive deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox) IV over 4 hours on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of Combotox until the maximum tolerated dose is determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adult acute lymphoblastic leukemia
- •B-cell lineage
- •Refractory or relapsed disease based on a bone marrow/peripheral blood examination, cytogenetic studies, or polymerase chain reaction amplification
- •Disease refractory to conventional therapy and other therapies of higher priority
- •At least 50% of the blasts (in bone marrow or peripheral blood) expressing CD19 and/or CD22 by flow cytometry
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 2 months
- •Creatinine < 1.5 times normal
- •Bilirubin < 1.5 times normal
- •ALT or AST < 2.5 times normal
- •PRIOR CONCURRENT THERAPY:
- •Prior chemotherapy, biologic therapy, and/or radiotherapy allowed
排除标准
- 未提供
研究组 & 干预措施
Combination Therapy with Immunotoxins Imtox 19 Plus Imtox 22
干预措施: deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins (Biological)
结局指标
主要结局
Optimum dose of deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins (Combotox)
Efficacy of treatment
次要结局
未报告次要终点