NCT05578378招募中2 期
Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in Refractory/Relapsed Acute Lymphoblastic Leukemia
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- CR (complete remission rate)
研究概览
简要总结
To explore the efficiency and safety of CLAG regimen in R/R ALL
详细描述
R/R Acute Lymphoblastic Leukemia has poor response to second-line chemotherapy.Here,we want to explore efficiency and safety of CLAG regimen in R/R ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-
- •Expecting life span is more than 6 weeks.
排除标准
- •Patients are combined with severe organ dysfunction or organ failure: Cardiac failure, Liver and kidney insufficiency.
- •Patients are combined with severe infection or other complications that can not tolerate chemotherapy.
- •Patients are considered as other tumor progression. Patients have used cladribine. Pregnant and lactating women will not be included.
研究组 & 干预措施
CLAG arm
Experimental
Cladribine (5 mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.
干预措施: Cladribine (Drug)
Control arm
Active Comparator
Patients in the control arm received the investigator's choice of one of the following three regimens:
- FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.
- a high-dose cytosine arabinoside-based regimen;
- a high-dose methotrexate-based regimen
干预措施: Fludarabine (Drug)
结局指标
主要结局
CR (complete remission rate)
时间窗: the first cycle (4 weeks)
Response to CLAG regimen.
次要结局
- Progression-Free Survival （PFS）(From the 1st day to the 365th day after enrollment.)
- Overall survival(OS)(From the 1st day to the 365th day after enrollment.)
研究者
研究点 (1)
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