Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Drug: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Drug: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Phase II

MedlinePlus related topics:   Cancer   Fungal Infections   Hodgkin's Disease   Leukemia, Adult Acute   Leukemia, Adult Chronic   Leukemia, Childhood   Lymphoma   Multiple Myeloma  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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.

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2000

Detailed Description:

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.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005606

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Ann Traynor, MD     Robert H. Lurie Cancer Center    
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
      Chicago, Illinois, United States, 60611
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Study Chair:     Ann Traynor, MD     Robert H. Lurie Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067730, NU-98H1, NCI-G00-1739
First Received:   May 2, 2000
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00005606
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated hairy cell leukemia  
progressive hairy cell leukemia, initial treatment  
refractory hairy cell leukemia  
stage I adult Hodgkin lymphoma  
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
stage I cutaneous T-cell non-Hodgkin lymphoma  
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
stage 0 chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Sezary syndrome
Leukemia, Lymphoid
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Paraproteinemias
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Hemostatic Disorders
Acute lymphoblastic leukemia, adult
Lymphoma, B-Cell
Leukemia
Mycoses
Hemorrhagic Disorders
Multiple myeloma
Lymphoma, T-Cell
Plasmacytoma anaplastic
Hodgkin Disease

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders
Cardiovascular Diseases

Source: National Library of Medicine (NLM) July 10, 2008