NCT00154349已完成2 期
Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic 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
- 8
- 主要终点
- 3 month hematological response rate
研究概览
简要总结
The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed diagnosis of ALL.
- •Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
- •Patients in relapse
- •Patients refractory to initial remission induction therapy
- •Patients ineligible for initial remission induction therapy
- •Patients with an ECOG Performance Status Score from 0 to 2
- •Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)
- •AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN
- •Serum bilirubin level not more than 3 × ULN
排除标准
- •Patients with findings indicative of leukemic involvement of the central nervous system
- •Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
- •Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
- •Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
imatinib mesylate
Experimental
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
3 month hematological response rate
次要结局
- Duration of hematological response
- Survival
- Cytogenetic response in every 3 months
研究者
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