Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in coagulation - frequency
研究概览
简要总结
This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in pediatric ALL patients.
II. Compare bleeding and thrombotic events associated with Cal-PEG to historical controls treated with pegaspargase.
OUTLINE: This is an observational study.
Patients undergo collection of blood samples and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-21.5 years
- •Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
- •Planned treatment with Cal-PEG
- •Informed consent obtained from parents or guardians
排除标准
- •Pre-existing coagulation disorders
- •Known hypersensitivity to asparaginase products
- •Liver failure
- •Any acute or chronic disease that is known to affect coagulation testing (e.g. nephrotic syndrome)
- •Currently pregnant
- •Use of systemic blood thinner within 48 hours prior to study blood draw
研究组 & 干预措施
Observational
Patients undergo collection of blood samples and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Change in coagulation - frequency
时间窗: Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration
Frequency of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).
Change in coagulation - duration
时间窗: Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration
Duration of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).
Incidence of clinically relevant hematologic or thrombotic adverse events
时间窗: Up to 12 weeks
Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) criteria. Will describe clinically relevant hematologic or thrombotic adverse events in patients with ALL who receive Cal-PEG as part of their treatment.
次要结局
未报告次要终点