NCT00035880已完成2 期
A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial Evaluating ABX-CBL When Compared to Atgam as Second Line Therapy in Patients With Steroid Resistant Acute Graft Versus Host Disease
Abgenix2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 1999年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
研究概览
简要总结
Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of single allogeneic stem cell transplant from any donor type
- •Time post transplant less than 100 days
- •Received no treatment for GVHD other than steroids
排除标准
- •Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant
- •IBMTR index less than A
- •Received any murine product in the past
- •Diagnosed with chronic GVHD
- •Received Atgam later than day 10 post transplant
- •Change to prophylactic regimen for acute GVHD within 72 hours of randomization
研究者
研究点 (2)
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