NCT02544789已完成2 期
Phase II, Multi-center, and Pharmacokinetic Study of Efficacy, Safety and Pharmacokinetic of Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- overall response rate
研究概览
简要总结
Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients with R/R ALL
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (younger than 21 years old) with acute lymphoblastic leukemia confirmed by histology
- •Refractory or relapsed acute lymphocytic leukemia who had received at least two drugs treatment
- •No prior chemotherapy within 2 weeks before entry and resolution of toxic effects from prior therapy
- •Normal cardiac function, adequate hepatic function [total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) alanine aminotransferase (ALT) ≤ 3ULN] and renal function (serum creatinine ≤ 2 ULN)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy more than 3 months
排除标准
- •AEs not recovered from prior therapy
- •Within 3 months from allogeneic or autologous stem cell transplantation
- •With central nervous involvement or uncontrolled infection
- •Patients who used clofarabine before or allergic to fludarabine or cladribine
研究组 & 干预措施
clofarabine
Experimental
Clofarabine (Betta Pharmaceuticals Co., Ltd, Zhejiang, China) was administered intravenously at 52 mg/m2 over 2 hours daily for 5 consecutive days. During the first two induction cycles, patients who did not achieve an objective response were taken off the study, and responsive patients continued to receive consolidation for a maximum 11 cycles if non-hematological toxicity was grade 2 or less.
干预措施: Clofarabine (Drug)
结局指标
主要结局
overall response rate
时间窗: 8 weeks
次要结局
- patients suffering adverse events(8 weeks)
研究者
研究点 (6)
Loading locations...
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