Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation
NCT ID: NCT00005606
Last Updated: 2012-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2000-02-29
2003-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Ann Traynor, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-98H1
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1739
Identifier Type: -
Identifier Source: secondary_id
NU 98H1
Identifier Type: -
Identifier Source: org_study_id
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