NCT02150928撤回2 期
An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) Administered Following Hypersensitivity to E. Coli Asparaginase in Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum asparaginase activity levels
研究概览
简要总结
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of ALL or LBL
- •Be 18 to <40 years of age at the time of enrollment
- •Have a documented ≥ Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
- •Have the following asparaginase doses remaining in their treatment plan:
- •At least two (2) consecutive weeks of native E. coli asparaginase treatment OR
- •At least one (1) dose of pegaspargase (Oncaspar)
- •Have a direct bilirubin ≤ Grade 2 (<3.0 mg/dL [52 µmol/L])
- •Have amylase and lipase within normal limits (per institutional standards)
- •Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinaze)
- •Consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months prior to baseline), and progestin implant or injection.
- •Have signed informed consent
排除标准
- •Prior history of ≥ Grade 3 pancreatitis
- •Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
- •Prior treatment with Erwinaze
- •Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
- •Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
- •Any other condition that would cause a risk (in the investigator's judgment) to subjects if they participate in the trial
研究组 & 干预措施
Erwinaze / Erwinase
Experimental
干预措施: Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase) (Drug)
结局指标
主要结局
Serum asparaginase activity levels
时间窗: 48 h postdose 5
次要结局
未报告次要终点
研究者
研究点 (1)
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