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| ID | Type | Description | Link |
|---|---|---|---|
| UAB-9739 | |||
| IUMC-9611-37 | |||
| NCI-V97-1176 |
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RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.
PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.
OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.
OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.
PROJECTED ACCRUAL: 10 patients will be accrued in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infusions of EBV specific cytotoxic T lymphocytes | Experimental | Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients | baseline to x weeks post infusion | |
| Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions. | baseline to x weeks past infusion |
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Inclusion criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth G. Lucas, MD | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
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