Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 43
- 主要终点
- Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL
研究概览
简要总结
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.
II. To determine the frequency of asparaginase-related toxicity in these patients.
III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
SECONDARY OBJECTIVES:
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
- •Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
- •Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
- •Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
- •No history of pancreatitis ? grade 2
- •No prior Erwinia asparaginase
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy)
Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
干预措施: Asparaginase (Drug)
Treatment (chemotherapy)
Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (chemotherapy)
Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL
时间窗: 48 hours post administration of Erwinia asparaginase
Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase
次要结局
- Determine if Plasma Asparagine is Adequately Depleted(On days 12 or 13)
- Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase(At baseline, prior to doses 4, 5, and 6 and on days 15 and 22)
- Percentage of Participants Who Experienced Toxicities(up to 1 year)