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NCT00058604 · ClinicalTrials.gov registry record · Phase 1
Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).
A Phase 1 study of Lymphoproliferative Disorders and Epstein-Barr Virus Infections, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT00058604 is a Phase 1 study of Lymphoproliferative Disorders and Epstein-Barr Virus Infections that has completed, run by Baylor College of Medicine. The registered enrollment target is 12 participants, below the 239-participant average among 12 other Lymphoproliferative Disorders trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00058604, a Phase 1 study of Lymphoproliferative Disorders and Epstein-Barr Virus Infections, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
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
Conditions Studied
Interventions
- BIOLOGICAL Intravenous injection of EBV specific CTLs
Study Locations (2)
Texas
- Texas Children's Hospital - Houston
- The Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2001-01 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058604
The ClinicalTrials.gov registry entry for NCT00058604 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 12 other Lymphoproliferative Disorders trials with a reported enrollment target (95% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lymphoproliferative Disorders appearing as the primary indexed condition, and to 1 intervention - of which Intravenous injection of EBV specific CTLs is the first listed.
NCT00058604 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00058604 about?
NCT00058604 is a clinical study titled "Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).". 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 lympho...
What is the current status of trial NCT00058604?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2001-01. Estimated completion is 2008-12.
What conditions does trial NCT00058604 study?
This clinical trial studies the following conditions: Lymphoproliferative Disorders, Epstein-Barr Virus Infections.
What interventions are being tested in trial NCT00058604?
The interventions under investigation include: Intravenous injection of EBV specific CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058604?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00058604 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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