NCT00032773终止1 期
A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 6 months of age with grade 2 GVHD that is steroid-refractory
- •Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC
- •Time post stem cell infusion < 100 days
- •Written informed consent
- •Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2)
排除标准
- •Post-transplant lymphoproliferative disease
- •Uncontrolled infection
- •Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study
- •ATG within the previous 14 days
- •Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days
研究者
研究点 (1)
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