NCT00201786已完成2 期
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease
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
- 试验地点
- 1
- 主要终点
- Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
研究概览
简要总结
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
- •No chronic GVHD
- •Age ≥ 18 years
- •Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
- •Performance status 0-3
排除标准
- •Patients on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry.
- •Patients on renal dialysis or who have an estimated creatinine clearance of < 30 ml/min/1.73 m
- •Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
研究组 & 干预措施
Pentostatin
Experimental
Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS.
干预措施: Pentostatin (Drug)
结局指标
主要结局
Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease).
时间窗: up to 2 years
次要结局
- Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC).(up to 2 years)
研究者
Craig Hofmeister
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (1)
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