Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Participant Toxicity Data
研究概览
简要总结
The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.
This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.
详细描述
The Study Drug:
Erwinia L-Asparaginase helps stop the growth of cancer cells by blocking the nutrients that cancer cells needed to survive.
Study Visits:
Erwinia L-Asparaginase will be given either outpatient or inpatient, depending upon your condition.
If you are allergic to E. Coli Asparaginase or Pegylated Asparaginase, you will be given 6 doses every other day.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: no restrictions
- •Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND)
- •Patient must be treated for Acute Lymphoblastic Leukemia
- •Patient with either T or B cell lymphoma being treated with Asparaginase.
- •Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.
- •Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
- •Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.
排除标准
- •Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
- •Previous acute pancreatitis
- •Pregnant or lactating woman
研究组 & 干预措施
Erwinase
6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
干预措施: Erwinase (Drug)
结局指标
主要结局
Participant Toxicity Data
时间窗: 3 Years
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma
时间窗: 4 years
Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.
次要结局
未报告次要终点