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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 |
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes |
Phase II |
| 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 | |
| Study Chair: | Ann Traynor, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000067730, NU-98H1, NCI-G00-1739 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005606 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia untreated adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia |
|
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Hodgkin Lymphoma, Childhood Blood Protein Disorders Paraproteinemias Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Hemostatic Disorders Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Leukemia Mycoses Hemorrhagic Disorders Cutaneous T-cell Lymphoma |
Leukemia, Lymphocytic, Chronic, B-Cell Plasmacytoma Anaplastic Lymphoma, T-Cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases Blood Coagulation Disorders Leukemia-Lymphoma, Adult T-Cell Hairy Cell Leukemia Vascular Diseases |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma |
Leukemia Lymphatic Diseases Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
