Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute hematotoxicity at 10 weeks following study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.
详细描述
OBJECTIVES:
- Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5 days (standard dose).
- Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
CDA day
CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
干预措施: 2-chlorodeoxyadenosine (CDA) daily (Drug)
CDA week
CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
干预措施: 2-chlorodeoxyadenosine weekly (Drug)
结局指标
主要结局
Acute hematotoxicity at 10 weeks following study treatment
时间窗: 10 weeks
Acute infection rate at 10 weeks following study treatment
时间窗: 10 weeks
次要结局
- Hospital admission frequency and length at 10 weeks following study treatment(10 weeks)
- Blood support at 10 weeks following study treatment(10 weeks)
- Remission rate(10 weeks)
- Remission duration(10 weeks)
- Relapse-free survival(10 weeks)