A Phase II Trial of Cytarabine and Clofarabine in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 91
- 主要终点
- Number of Patients With Complete Remission
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving cytarabine together with clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.
详细描述
Primary objective:
- Determine whether the complete remission rate in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) is sufficiently high after treatment with cytarabine and clofarabine to warrant further investigation.
Secondary objectives:
- Estimate the frequency and severity of toxicities associated with this dosing schedule of cytarabine and clofarabine.
- Investigate, preliminarily, the prognostic effects of cytogenetic features on response to treatment in these patients.
Other objectives (if funding allows):
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
- 16 Years 至 —（Child, Adult, Older 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
Induc, ReInduc, Consol, clofarabine, cytarabine
Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
干预措施: clofarabine (Drug)
Induc, ReInduc, Consol, clofarabine, cytarabine
Induction: 40mg/m2/d; IV over 1 hr; days 1-5 Re-induction (if necessary): 40mg/m2/d; IV over 1 hr; days 1-5 Consolidation: 40mg/m2/d; IV over 1 hr; days 1-4
干预措施: cytarabine (Drug)
结局指标
主要结局
Number of Patients With Complete Remission
时间窗: Between day 28 and day 35 inclusive
Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease
次要结局
- Expression of Nucleoside Transporters(On average, two weeks before treatment started)
- Number of Patients With Very Poor Risk Cytogenetics(On average, 2 weeks before treatment started)
- Toxicity(Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle)