NCT01643408已完成2 期
Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 22
- 主要终点
- Two Day Nadir Serum Asparaginase Activity (NSAA) Level
研究概览
简要总结
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
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
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma,
- •Ages >/= 1 and </= to 30 years at the time of initial diagnosis
- •Undergoing asparaginase treatment for ALL or lymphoblastic lymphoma
- •Documented Grade 2 or higher hypersensitivity reaction to native or pegylated E. coli asparaginase or Calaspargase pegol
- •Must have two remaining weeks of native E. coli asparaginase treatment or 1 remaining dose of either Pegaspargase or Calaspargase pegol
- •Direct bilirubin less than or equal to Grade 2
- •Amylase and lipase within normal limits (per institutional standards)
- •Signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old.
排除标准
- 未提供
研究组 & 干预措施
Open-Label Erwinaze
Experimental
干预措施: asparaginase Erwinia chrysanthemi (Drug)
结局指标
主要结局
Two Day Nadir Serum Asparaginase Activity (NSAA) Level
时间窗: 48 hours post-dose 5
To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.
次要结局
- Nadir Serum Asparaginase Activity Over Time(4 weeks to 30 weeks)
- Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours(48 hours post-dose 5)
- Three Day NSAA Level(72 hours post-dose 6)
- Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours(72 hours post-dose 6)
研究者
研究点 (22)
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