NCT00109993已完成2 期
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Graft-vs-host disease response
研究概览
简要总结
RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.
PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.
Secondary
- Determine the best response at 4 and 12 weeks in patients treated with this regimen.
- Determine 6-month survival of patients treated with this regimen.
- Determine the rate of infectious complications in patients treated with this regimen.
- Determine rate of chronic GVHD 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
- Supportive Care
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute graft-vs-host disease (GVHD)
- •Clinical grade C or D disease
- •No grade C disease with single organ skin involvement
- •Has undergone allogeneic stem cell transplantation within the past 100 days
- •Absolute neutrophil count > 500/mm^3 (donor-derived [> 60% by peripheral blood lymphocyte chimerism analyses])
- •No development of GVHD after prior donor lymphocyte infusion
- •Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •No serologic evidence of active hepatitis B or C infection
- •Creatinine ≤ 3.5 mg/dL
- •No requirement for dialysis
- •Cardiovascular
- •No requirement for vasopressors
- •No requirement for a ventilator
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No known HIV positivity
- •No active uncontrolled infection
- •No other organ dysfunction
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Graft-vs-host disease response
时间窗: 1, 2, 3, and 4 months
次要结局
- Incidence of serious infections by clinical, radiologic, and microbiologic assessments(1,2,3, and 4 months)
研究者
研究点 (6)
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