Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006100
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

August 3, 2000
January 27, 2003
December 18, 2013
April 2000
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Complete list of historical versions of study NCT00006100 on Archive Site
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Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma.

PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.


  • Determine the toxicity of allogeneic Epstein Barr virus (EBV)-specific cytotoxic T-lymphocytes (EBV CTL) in patients with progressive, relapsed, or refractory EBV-positive Hodgkin's lymphoma.
  • Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL.

OUTLINE: Donors undergo leukapheresis. Epstein Barr virus-specific cytotoxic T lymphocytes (EBV CTL) are cultured in vitro.

Patients receive an infusion of EBV CTL over 10 minutes on day 0. The EBV CTL infusion is preceded by 3 doses of fludarabine. Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion.

Patients are followed weekly for 1.5 months, twice a month for 1.5 months, and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Biological: aldesleukin
  • Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
  • Drug: fludarabine phosphate
  • Procedure: peripheral blood stem cell transplantation
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Lucas KG, Salzman D, Garcia A, Sun Q. Adoptive immunotherapy with allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes for recurrent, EBV-positive Hodgkin disease. Cancer. 2004 May 1;100(9):1892-901.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Histologically proven Hodgkin's lymphoma

    • Progressive, relapsed, or refractory disease after prior chemotherapy, radiotherapy, and/or stem cell transplantation
    • Epstein Barr virus (EBV) positive by immunohistochemical staining for LMP-1 or 2 OR the presence of EBV RNA (EBER)
  • Availability of an HLA identical or haploidentical donor for cytotoxic T-lymphocytes, meeting the following criteria:

    • EBV seropositive
    • HIV negative
    • HTLV-1 negative
    • Hepatitis B surface antigen and hepatitis B core antibody IgM negative
    • Hepatitis C antibody negative
    • Must share at least 1 HLA haplotype with donor



  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • At least 8 weeks


  • Not specified


  • Bilirubin less than 2.0 mg/dL
  • SGOT/SGPT less than 2.5 times normal (unless liver metastases are present)

    • If there is liver involvement by disease, an obvious relationship between SGOT/SGPT and disease activity is required
  • No hepatic dysfunction causing moribundity


  • Creatinine clearance greater than 50 mL/min
  • No renal dysfunction causing moribundity


  • No cardiac dysfunction causing moribundity


  • No pulmonary dysfunction causing moribundity


  • No neurologic dysfunction causing moribundity
  • No history of severe transfusion reactions with blood products (including fetal calf serum)
  • Not pregnant


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • No concurrent antimetabolites

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • Not specified
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Study Chair: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
National Cancer Institute (NCI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP