A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 44
- 主要终点
- Duration of severe neutropenia in chemotherapy in cycles 1 and 3
研究概览
简要总结
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Filgrastim
Filgrastim
干预措施: filgrastim (Drug)
Pegfilgrastim
Pegfilgrastim
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Duration of severe neutropenia in chemotherapy in cycles 1 and 3
时间窗: cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
时间窗: cycles 1 and 3
次要结局
- Pharmacokinetic profile in chemotherapy cycles 1 and 3(cycles 1 and 3)
- Incidence of adverse events across all cycles of chemotherapy(all cycles)
- Overall rates of febrile neutropenia(all cycles)