A Preliminary Study to Evaluate the Effects of Palifermin in Patients at Risk of Chronic Graft-versus-host Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
研究概览
简要总结
RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease caused by donor stem cell transplant.
PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer
详细描述
OBJECTIVES:
I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD).
II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.
OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not.
GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Survival for more than 60 days after an allogeneic hematopoietic cell transplantation (HCT) with growth-factor mobilized blood cells
- •Current dose of prednisone at =< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment
- •Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study
- •Able and willing to give informed consent
排除标准
- •Presence of generalized rash involving more than 50% of the body surface
- •Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment
- •Any prior local irradiation to a field that included the thymus (total body irradiation is allowed)
- •History of thymectomy
- •Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen
- •Use of a graft depleted of T cells
- •Any evidence of recurrent or persistent malignancy after HCT
- •Participation in another study with chronic GVHD as the primary endpoint
- •Any prior history of carcinoma
- •Any infection that is not improving during appropriate treatment
- •History of palifermin intolerance
- •A positive pregnancy test (women of child-bearing potential)
- •Breast feeding
研究组 & 干预措施
Arm I (palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
干预措施: flow cytometry (Other)
Arm I (palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I (palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
干预措施: pharmacological study (Other)
Arm II (no palifermin)
Patients do not receive palifermin.
干预措施: flow cytometry (Other)
Arm II (no palifermin)
Patients do not receive palifermin.
干预措施: laboratory biomarker analysis (Other)
Arm II (no palifermin)
Patients do not receive palifermin.
干预措施: pharmacological study (Other)
Arm I (palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
干预措施: palifermin (Biological)
结局指标
主要结局
Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood
时间窗: Baseline and 4 weeks after administration of palifermin
RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
次要结局
- Changes in the Number of Naive CD4 T Cells in the Blood(Baseline and 4 weeks after administration of palifermin)
研究者
Martin, Paul
Member
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium