跳至主要内容
临床试验/NCT00587054
NCT00587054已完成2 期

Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2001年6月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
129
试验地点
1
主要终点
Overall Survival of Transplant Patients

研究概览

简要总结

This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.

详细描述

The purpose of this study is: (1) to try to kill any cancer or precancer cells that are in your body, and to reduce the side effects of a transplant, which we have seen in our previous studies, (2) to see if this treatment with a new recipe of radiation and chemotherapy can suppress your immune system enough for the stem cells to 'take' and grow, (3) to see if the specially prepared stem cells can grow in you without a problem called graft-versus-host disease (GvHD) occurring.

One of the major side effects of any stem cell transplant is a condition known as graft vs. host disease or GVHD. GVHD is an immune reaction caused by certain cells from the transplanted stem cells called T-lymphocytes (or T-cells). The T-cells from your donor may see your organs as foreign and attack them. New ways to remove the T-cells from the stem cells before the transplant are being used to try and prevent GVHD. In some studies, the removal of T-cells from the stem cells has been successful for many patients in preventing both short-term (acute) and long-term (chronic) forms of GVHD. However, the removal of T-cells may increase the chance that the new bone marrow developing from the stem cells will be rejected or will not function well. Rejection of the transplant means that some of your own cells have survived the chemo and radiation therapy, and are attacking the new bone marrow cells. This condition can be lifethreatening because of an increased risk of infections and bleeding and would require your getting more treatment and additional stem cells. Studies like this one are designed to find better ways to avoid GVHD without increasing the risk of other problems such as graft rejection.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome
  • HLA 6/6 or 5/6 antigen matched related or unrelated donor
  • creatinine = normal or if not, CrCl > 60 ml/min/1.73ml
  • total bilirubin < 2.5, AST < 2xnl, cardiac function > 50%
  • pulmonary function - asymptomatic or if not DLCO > %50% (corrected for Hgb)
  • Karnofsky performance status > 70%
  • negative pregnancy test (where applicable)
  • signed informed consent of patient and donor.

排除标准

  • Pregnancy or lactation
  • unwillingness to comply with protocol treatment or follow-up
  • uncontrolled infection
  • HIV or HTLV positivity
  • active CNS/skin disease

研究组 & 干预措施

Transplant Patients

Experimental

干预措施: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant (Drug)

结局指标

主要结局

Overall Survival of Transplant Patients

时间窗: up to 6 years

Calculate the median overall survival of transplant patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

已完成
2 期
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast CancerFallopian Tube CancerPrimary Peritoneal CancerOvarian CancerBreast Cancer
NCT01105650Masonic Cancer Center, University of Minnesota13
Unknown
2 期
Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) PatientsNon-Hodgkin's Lymphoma
NCT00081783Xcyte Therapies40
进行中(未招募)
2 期
Lentiviral-mediated Gene Therapy for Pediatric Patients With Fanconi Anemia Subtype AFanconi Anemia Complementation Group A
NCT04069533Rocket Pharmaceuticals Inc.7
已完成
2 期
Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic MalignanciesBiphenotypic Acute LeukemiaUndifferentiated LeukemiaMyelodysplastic SyndromesMyeloproliferative NeoplasmRelapsed Large Cell LymphomaAcute Myeloid LeukemiaBurkitt LymphomaRelapsed T-Cell LymphomaRelapsed Chronic Lymphocytic LeukemiaRelapsed Small Lymphocytic LymphomaRelapsed Marginal B-cell LymphomaRelapsed Follicular LymphomaLymphoplasmacytic LymphomaAcute Lymphoblastic LeukemiaProlymphocytic LeukemiaMantle Cell LymphomaHodgkin LymphomaChronic Myelogenous Leukemia
NCT04191187H. Lee Moffitt Cancer Center and Research Institute34
进行中(未招募)
2 期
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell TransplantAcute Undifferentiated LeukemiaAcute Biphenotypic LeukemiaAcute Leukemia of Ambiguous LineageAllogeneic Hematopoietic Stem Cell Transplantation RecipientBlastic Plasmacytoid Dendritic Cell NeoplasmBlasts Under 25 Percent of Bone Marrow Nucleated CellsBlasts Under 5 Percent of Bone Marrow Nucleated CellsMyelodysplastic Syndrome With Excess Blasts-1Myelodysplastic Syndrome/Acute Myeloid LeukemiaBurkitt LeukemiaChronic Monocytic LeukemiaLymphoblastic LymphomaMyeloproliferative NeoplasmMast Cell LeukemiaAcute LeukemiaAcute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia
NCT03779854Fred Hutchinson Cancer Center45