NCT01283776已完成2 期
A Phase II Study to Investigate the Efficacy of Cyclophosphamide as Sole Graft-Versus-Host-Prophylaxis After Allogeneic Stem Cell Transplantation
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
- 11
- 试验地点
- 1
- 主要终点
- Number of patients not requiring additional immunosuppression
研究概览
简要总结
A phase II clinical study to assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with multiple myeloma, Non-Hodgkin's lymphoma or Hodgkin's disease after allogeneic stem cell transplantation with reduced intensity conditioning
- •Written informed consent
- •No uncontrolled infections
排除标准
- •Severe organ dysfunction defined as:
- •Cardiac left ventricular ejection fraction (LVEF) of less than 35%
- •diffusing lung capacity (DLCO) of less than 40%
- •total lung capacity (TLC) of less than 40%
- •forced expiratory volume (FEV1) of less than 40%
- •total bilirubin >3mg/dl
- •creatinine-clearance of less than 40 ml/min
- •pregnancy or breast feeding
- •participation in other experimental drug trials
研究组 & 干预措施
treatment arm
Experimental
Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of patients not requiring additional immunosuppression
时间窗: day 100 after transplant
The primary endpoint is met if at least 1 of the 5 first patients and 3 of a total of 11 patient will reach day 100 after transplant without additional immunsuppressive drug treatment
次要结局
- Overall Survival(day 100 after transplant)
- immune reconstitution(day 100 after transplant)
- engraftment(day 100 after transplant)
- chimerism(day 100 after transplant)
- acute GvHD(day 100 after transplant)
- non-relapse mortality(day 100 after transplant)
- relapse incidence(day 100 after transplant)
研究者
Christoph Scheid
PD Dr. Christoph Scheid
University of Cologne
研究点 (1)
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