Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).

Completed · Phase 1

Conditions studied: Epstein-Barr Virus Infections, Lymphoproliferative Disorders

In brief

Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may already have a form of this disease. This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). These cells have been trained to attack and kill (cytotoxic) EB virus infected cells. We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells. This stimulation will train the T cells to kill EBV infected cells. We will then test the T cells to make sure they kill the EBV infected cells. 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 prevent or cure EBV related cancers in solid organ transplant patients

Key facts

Study ID: NCT00058604
Run by: Baylor College of Medicine
People needed: 12
Starts: 2001-01-01
Expected to finish: 2008-12-01
Last updated by the study team: 2020-01-18

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients falling into one of the following categories:
Organ transplant recipients at high risk of developing LPD:
EBV seronegative recipients
Organ transplant recipients receiving OKT3 for immunosuppression
Organ transplant recipients with evidence of LPD
Organ transplant recipients with EBV DNA level >1,000 copies
Age <70 yrs old
Signed informed consent obtained from patient/guardian
CTLs available
Performance status; ECOG £ 2
Creatinine < 3X normal
Bilirubin < 5X normal
AST < 5X normal
Has not received any other investigational cellular therapies within the past 30 days.

You may not qualify if…

Patients with a severe intercurrent infection
Patients with life expectancy of less than 6 weeks
Patients receiving supplemental oxygen.

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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