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NCT00058773 · ClinicalTrials.gov registry record · Phase 1
Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00058773: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT00058773 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058773, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation. Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells and give them back to subjects.
Primary Outcome
The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.
Interventions
- DRUG Infusion of EBV Specific Cytotoxic T-Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 1996-01 |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
Why NCT00058773 stopped before completion
NCT00058773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Infusion of EBV Specific Cytotoxic T-Lymphocytes is the first listed.
NCT00058773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00058773 about?
NCT00058773 is a clinical study titled "Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease". Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr virus (EBV) specific c...
What is the current status of trial NCT00058773?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 1996-01. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00058773?
The interventions under investigation include: Infusion of EBV Specific Cytotoxic T-Lymphocytes (DRUG).
Who is sponsoring clinical trial NCT00058773?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00058773's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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