NCT00096096已完成2 期
A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the safety of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following hematologic malignancies:
- •Acute myeloid leukemia beyond first complete remission (CR1)
- •Acute lymphoblastic leukemia beyond CR1
- •Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase
- •Non-Hodgkin's lymphoma beyond CR2
- •Hodgkin's lymphoma beyond CR2
- •Multiple myeloma (any stage)
- •Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia)
- •Any refractory hematologic malignancy
- •Advanced disease
- •Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells
- •Genotypically HLA-identical stem cell donor available
- •PATIENT CHARACTERISTICS:
- •65 and under
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT ≤ 2.0 times ULN
- •Creatinine clearance ≥ 60 mL/min
- •No acute pulmonary infection by chest x-ray
- •No severe hypoxemia (partial O_2 < 70% of predicted) AND DLCO < 70% of predicted
- •No mild hypoxemia (partial O_2 < 80% of predicted) AND DLCO < 60% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •No active systemic infection not controlled with antimicrobial therapy
- •HIV negative (HIV-1 or other virus)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent T-cell depleted hematopoietic stem cell graft
- •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
Efficacy
次要结局
- Safety
- Area under the curve of plasma mycophenolic acid
研究者
研究点 (1)
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