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临床试验/NCT00005606
NCT00005606已完成2 期

Adoptive Immunotherapy of Epstein Barr Virus Induced Lymhoproliferative Disease. A Comparison of Allogeneic and Autologous Lymphocyte Responses ex Vivo and Use of Highly Selected Reactive Cells as an Alternative to Chemotherapy in Vivo.

Northwestern University2 个研究点 分布在 1 个国家开始时间: 2000年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
试验地点
2

研究概览

简要总结

RATIONALE: Peripheral blood lymphocyte therapy may be effective in the treatment and prevention of Epstein-Barr virus infection following transplantation.

PURPOSE: Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus infection following transplantation.

详细描述

OBJECTIVES:

  • Compare the efficacy of Epstein Barr virus (EBV) reactive autologous and allogeneic lymphocyte clones ex vivo in targeting EBV immortalized lymphoblasts in patients undergoing a solid organ transplant or T cell depleted bone marrow transplant.
  • Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease.

OUTLINE: Autologous and allogeneic Epstein Barr virus (EBV) reactive lymphocytes are isolated from patients and siblings and tested in vitro for cytotoxic activity.

Patients who develop EBV viremia or EBV related lymphoproliferative disease after transplant receive autologous Epstein Barr virus (EBV) reactive lymphocytes IV over 20 minutes. Patients receive allogeneic EBV reactive lymphocytes if autologous lymphocytes fail to control EBV proliferation or when sufficient autologous reactive lymphocytes cannot be isolated. Treatment repeats every 4 weeks in the presence of EBV viremia or lymphoproliferative disease. After 5 patients have received therapy without unacceptable toxicity, patients may receive lymphocytes as prophylactic therapy.

Patients are followed at 4 weeks, 8 weeks, 6 months, and 12 months.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

性别
All
接受健康志愿者

入选标准

  • DISEASE CHARACTERISTICS:
  • Patients who have received or will receive a solid organ transplant or T cell depleted bone marrow transplant
  • Epstein Barr virus (EBV) DNA detectable and seronegative OR
  • EBV seropositive
  • Fully matched or one HLA antigen mismatched sibling donor
  • HIV negative
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • No older than 65 years
  • No prior primary malignancy within the past 5 years in donor except previously resected skin cancer
  • PATIENT CHARACTERISTICS:
  • Not specified
  • Performance status:
  • Not specified
  • Life expectancy:
  • Not specified
  • Hematopoietic:
  • Not specified
  • Not specified
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Not specified

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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