NCT07221656尚未招募不适用
Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of therapeutic SAA
研究概览
简要总结
This study evaluates the median duration of therapeutic serum asparaginase activity (SAA) levels after administration of calaspargase pegol (Cal-PEG) and the potential association between peak SAA levels and duration of therapeutic levels with toxicity in pediatric patients with acute lymphoblastic leukemia or lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team
- •Receiving calaspargase as part of treatment for malignancy
排除标准
- •Age > 21 years
- •Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm
- •Pregnancy
结局指标
主要结局
Duration of therapeutic SAA
时间窗: Up to 15 months
Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.
次要结局
未报告次要终点
研究者
研究点 (1)
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