NCT01385891已完成2 期
Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
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
- 40
- 试验地点
- 1
- 主要终点
- response to treatment
研究概览
简要总结
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
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 Month 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of > 25% of blast in bone marrow
- •treatment with second line therapies
- •patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration
- •children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
- •Relapsed after > months after SCT
- •Karnofsky score >50
- •a Forced Espiratory Volume >30%
- •sufficient hepatic and renal function defined as creatinine levels <2 × ULN, bilirubin <1.5 × ULN
- •aspartate and alanine aminotransferases <10 × ULN.
排除标准
- •isolated extra-medullary relapse, and active infections
研究组 & 干预措施
children with advanced leukemia
Experimental
干预措施: Clofarabine VP 16 ciclophospahamide (Drug)
结局指标
主要结局
response to treatment
时间窗: after an expected average of 3 weeks after the first dose of each chemotherapy course
次要结局
- Number of patients with toxicity as a measure of safety and tolerability(at an expected average of 4 weeks after the first dose of each chemotherapy course)
研究者
研究点 (1)
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