A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies

Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点分布在 1 个国家目标入组 14 人开始时间: 2004年3月最近更新: 2016年11月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Sidney Kimmel Cancer Center at Thomas Jefferson University
入组人数: 14
试验地点: 1
主要终点: Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this research study is to determine if an experimental agent, LLME can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following blood (hematopoietic) stem cell transplantation

详细描述

We believe that the risks of allogeneic transplant can be drastically reduced if the following criteria can be met: (1) consistent engraftment, (2) little or no GVHD with the ability to rapidly withdraw immune suppression, (3) rapid recovery of CD4 counts to levels greater than 200 cells/micro liter. Our prior (ongoing) trial attempts to address how LLME treated T cells given as donor lymphocyte infusion (DLI) can address points 2 and 3 above. The current study addresses how treatment of the CD34- fraction of the graft attempts to address points 1 and 2 (and to a lesser extent point 3) above. We believe that if these points can be consistently achieved that the mortality of allogeneic HSCT may be reduced to levels more akin to those of autologous HSCT. We propose to test the hypothesis that LLME-treated T cells will be safe with regard to reducing GVHD or other infusion related toxicities and that their administration as part of the transplant will facilitate engraftment. We believe that this approach will ultimately be an important step in a variety of transplant settings ranging from matched siblings to haplodisparate donors.

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

•Patients must be > 18 years of age, with no upper age limit.
•Patients must have an ECOG performance status of 0 or
•Any patient with a hematologic malignancy which is unlikely to be cured by conventional treatment is eligible for this study.
•Patients for whom a disease specific protocol exists will be transplanted on those protocols as discussed in the introduction.
•Patients who have had prior autografts may be treated on this protocol.
•Patients must have adequate physical function as measured by the following criteria:
•Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be >40%.
•Hepatic: Aspartate transaminase (AST) micro 3x the upper limits of normal and total serum bilirubin < 2.5 mg/dL. Patients with a higher bilirubin from "benign conditions" such as Gilbert's disease may still be eligible for the study.
•Renal: Serum creatinine within the normal range or if creatinine outside normal range then creatinine clearance > 60 ml/min/1.73m
•Serum creatinine must be less than or equal to 2.0 mg/dl.
•Pulmonary: Asymptomatic or, if symptomatic, DLCO (diffusion capacity) > 45% of predicted (corrected for hemoglobin)
•The patient or guardian(s) must be able to give informed consent to the study.
•Patient must have a suitable donor who is identical for HLA (human leukocyte antigens) -A, -B, -C, -DR. Single antigen mismatches for HLA-A, -B, -C, -DR are also permitted. Donors obtained through the National Marrow Donor Program (NMDP) will follow NMDP guidelines.

排除标准

•Patients who are eligible for a standard myeloablative transplant and for whom a standard myeloablative transplant is preferable will not be treated on this protocol.