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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005606 |
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 |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| 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. |
| Study Start Date: | February 2000 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Patients who have received or will receive a solid organ transplant or T cell depleted bone marrow transplant
Fully matched or one HLA antigen mismatched sibling donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| 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
|
| Study ID Numbers: | CDR0000067730, NU-98H1, NCI-G00-1739 |
| First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005606 |
| Health Authority: | United States: Federal Government |
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