A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Patients With Overall Survival
研究概览
简要总结
This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.
详细描述
This research protocol has been developed for patients undergoing matched-sibling hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2 step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT. The primary research questions relate to immune reconstitution, incidence of GVHD, and relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how it impacts overall survival.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:
- •Age > 50 years
- •ECOG Performance status of <2
- •Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL
- •CML 2nd chronic phase, accelerated phase, or blastic phase
- •MDS with IPS of Intermediate 2 or greater
- •Any myeloproliferative disorder
- •Hodgkin lymphoma: relapsed, refractory, or primary induction failure
- •Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT
- •Other conditions not listed will be assessed as high-risk by the PI
- •Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.
- •Patients must adequate organ function:
- •LVEF of >45%
- •DLCO (adjusted for hemoglobin) >45% of predicted
- •Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal
- •Creatinine clearance of > 60 ml/min
- •Patients must be willing to use contraception if they have childbearing potential
- •Able to give informed consent
排除标准
- •ECOG performance status of 3 or
- •HIV positive
- •Active involvement of the central nervous system with malignancy
- •Psychiatric disorder that would preclude patients from signing an informed consent
- •Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.
研究组 & 干预措施
Allogeneic Transplantation
Matched Sibling Allogeneic Transplantation
干预措施: Matched Sibling Allogeneic Transplantation (Device)
结局指标
主要结局
Number of Patients With Overall Survival
时间窗: 1 Year after transplant
The primary objective of this prospective, phase II trial was to obtain an OS rate of \>60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The \>60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.
次要结局
- Graft Versus Host Disease (GVHD)(1 Year after transplant)