临床试验/NCT07221656

NCT07221656尚未招募不适用

Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

Mayo Clinic1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2026年2月1日最近更新: 2025年11月21日

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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

Mayo Clinic

申办方类型

Other

责任方

Sponsor

研究点 (1)

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