T Lymphocytes in Treating Patients Undergoing a Donor Bone Marrow Transplant
Summary
RATIONALE: Donor T lymphocytes that have been treated with the Epstein-Barr virus may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best way to give T lymphocytes in treating patients undergoing a donor bone marrow transplant.
Description
OBJECTIVES:
- To generate Epstein-Barr virus (EBV)-specific cytotoxic T-cell lines from bone marrow transplantation (BMT) donors.
- To determine the safety of one intravenous injection of BMT donor-derived EBV-specific cytotoxic T lymphocytes (CTLs) in BMT recipients at high risk.
- To compare the antiviral and immunological efficacy of a single dose of CTLs versus the multiple dose regimens previously employed.
OUTLINE: Patients receive an infusion of Epstein-Barr Virus (EBV)-specific T cells on or after day 45 of an allogeneic stem cell transplantation regimen. EBV DNA persistence in peripheral blood is monitored by polymerase chain reaction before and after the infusion. Patients with EBV DNA levels above 1000 copies/μg or with persistent disease may receive up to 5 additional infusions of cytotoxic T lymphocytes (CTLs). Treatment repeats every 6 weeks in the absence of unacceptable toxicity.
Patients undergo blood sample collection periodically for immunophenotyping and tetramer analysis, assessment of EBV DNA content, and for reactivation of EBV-specific CTL lines to analyze specificity.
After completion of study treatment, patients are followed weekly for 6 weeks and then every 3 months for up to 1 year.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Cancer
Intervention
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes, polymerase chain reaction, immunological diagnostic method, adjuvant therapy
Location
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston
Texas
United States
77030
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00608309
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Infectious Mononucleosis
A common, acute infection usually caused by the Epstein-Barr virus (HERPESVIRUS 4, HUMAN). There is an increase in mononuclear white blood cells and other atypical lymphocytes, generalized lymphadenopathy, splenomegaly, and occasionally hepatomegaly with hepatitis.
Cd8-positive T-lymphocytes
A critical subpopulation of regulatory T-lymphocytes involved in MHC Class I-restricted interactions. They include both cytotoxic T-lymphocytes (T-LYMPHOCYTES, CYTOTOXIC) and CD8+ suppressor T-lymphocytes.
T-lymphocytes
Lymphocytes responsible for cell-mediated immunity. Two types have been identified - cytotoxic (T-LYMPHOCYTES, CYTOTOXIC) and helper T-lymphocytes (T-LYMPHOCYTES, HELPER-INDUCER). They are formed when lymphocytes circulate through the THYMUS GLAND and differentiate to thymocytes. When exposed to an antigen, they divide rapidly and produce large numbers of new T cells sensitized to that antigen.
Leukoplakia, Hairy
Epithelial hyperplasia of the oral mucosa associated with Epstein-Barr virus (HERPESVIRUS 4, HUMAN) and found almost exclusively in persons with HIV infection. The lesion consists of a white patch that is often corrugated or hairy.
Lymphocryptovirus
A genus of the family HERPESVIRIDAE, subfamily GAMMAHERPESVIRINAE, infecting B-cells in humans and new world primates. The type species human herpesvirus 4 (HERPESVIRUS 4, HUMAN) is better known as the Epstein-Barr virus.
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