NCT00683046已完成2 期
T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
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
- 204
- 试验地点
- 1
- 主要终点
- Median Disease-free Survival
研究概览
简要总结
Objectives:
- To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
- To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
- To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
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
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Zubrod performance status 2 (See Appendix B).
- •Life expectancy is not severely limited by concomitant illness.
- •Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
- •Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min .
- •Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal
- •No evidence of chronic active hepatitis or cirrhosis.
- •HIV-negative
- •Patient is not pregnant
- •Patient or guardian able to sign informed consent.
排除标准
- 未提供
研究组 & 干预措施
Drug Intervention
Experimental
干预措施: Fludarabine (Drug)
Drug Intervention
Experimental
干预措施: Melphalan (Drug)
Drug Intervention
Experimental
干预措施: Stem cells (Drug)
Drug Intervention
Experimental
干预措施: Campath (Drug)
结局指标
主要结局
Median Disease-free Survival
时间窗: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
次要结局
- Median Overall Survival(Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years)
研究者
研究点 (1)
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