NCT01244906已完成2 期
A Phase II Trial of Post-Transplant Cyclophosphamide and Sirolimus for Graft-versus-host Disease (GVHD) Prophylaxis Following Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Incidence of GVHD
研究概览
简要总结
This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor
- •Age 18-75
- •One of the following high-risk malignancies
- •Chronic Myelogenous Leukemia
- •Acute Myelogenous Leukemia
- •Myelodysplastic Syndrome
- •Myelofibrosis
- •Acute Lymphocytic Leukemia
- •Acute Lymphoblastic Lymphoma
- •Chronic Lymphocytic Leukemia
- •Prolymphocytic Leukemia
- •Low-grade non-Hodgkin's Lymphoma
- •Mantle Cell Lymphoma
- •Hodgkin Lymphoma
排除标准
- •Poor cardiac function (EF <40%)
- •Poor pulmonary function (FEV1 and FVC <50% predicted)
- •Poor liver function (bilirubin >/= 2 mg/dl not due to hemolysis, Gilbert's or primary malignancy)
- •Poor renal function (creatinine >/= 2 mg/dl or creatinine clearance <40mL/min)
- •Karnofsky status <70%
- •HIV positive
结局指标
主要结局
Incidence of GVHD
时间窗: 1 year
To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.
次要结局
- Number of Patients With Disease Free Survival at 2 Years(2 years)
- Number of Participants With Non-Relapse Mortality(1 year)
- Number of Patients to Achieve Full Donor Chimerism(1 year)
- Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment(Approximately Day 30)
- Number of Patients With Overall Survival at 2 Years.(2 years)
研究者
研究点 (2)
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