NCT00486421已完成早期 1 期
A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Failure-free survival at 6 months
研究概览
简要总结
RATIONALE: Rituximab and prednisone may increase the number of platelets in patients with immune thrombocytopenic purpura.
PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of rituximab, when administered with standard prednisone treatment, in maintaining a platelet count ≥ 50,000/mm³ at 6 months without further therapies (e.g., splenectomy or other salvage therapies) in patients with immune thrombocytopenic purpura.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the time to platelet recovery in patients treated with this regimen.
- Determine the duration of platelet recovery in patients treated with this regimen.
- Assess efficacy of this regimen in preventing spontaneous bleeding events in these patients.
- Determine the response in patients treated with this regimen.
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
- 21 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
PRED & RITUX
Experimental
干预措施: Rituximab (Biological)
PRED & RITUX
Experimental
干预措施: Prednisone (Drug)
结局指标
主要结局
Failure-free survival at 6 months
时间窗: 6 months
次要结局
- Time to platelet recovery(1 year)
- Duration of platelet recovery(1 year)
- Effect of treatment on prevention of spontaneous bleeding events(1 year)
研究者
研究点 (1)
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