Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs)
Completed · Phase 1
Conditions studied: Epstein-Barr Virus Infections
In brief
Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available. This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.
Key facts
- Study ID
- NCT00058591
- Run by
- Baylor College of Medicine
- People needed
- 13
- Starts
- 2000-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2020-01-18
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have severe chronic EBV infection as manifested by 6 months of symptoms Either elevated peripheral blood EBV DNA (>4000 genomes per ug PBMC DNA) or free EBV DNA in serum or CSF or VCA antibody titer > 1/640
- Seronegative for HIV
- Not on investigational agents in the last 4 weeks
- Signed informed consent obtained from patient/guardian
- CTLs available
- Performance status; Karnofsky >60
- Creatinine < 3X normal
- Bilirubin < 5X normal
- Normal electrolytes, calcium, phosphorus, nutritional status
- Females with child-bearing potential must utilize effective birth control.
You may not qualify if…
- Patients with a severe intercurrent infection
- Patients that recently received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
- Patients with life expectancy of less than 6 weeks
- Pregnant or lactating females
Where it is running
- Texas Children's Hospital — Houston, Texas, United States
- The Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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