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NCT00058617 · ClinicalTrials.gov registry record · Phase 1
Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells, Relapsed Lymphoma, ANGEL
A Phase 1 study of Epstein-Barr Virus-Related Hodgkin Lymphoma and Epstein-Barr Virus-Related Non-Hodgkin Lymphoma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT00058617: Completed Phase 1 study of Epstein-Barr Virus-Related Hodgkin Lymphoma and Epstein-Barr Virus-Related Non-Hodgkin Lymphoma, sponsored by Baylor College of Medicine.
NCT00058617 is a Phase 1 study of Epstein-Barr Virus-Related Hodgkin Lymphoma and Epstein-Barr Virus-Related Non-Hodgkin Lymphoma that has completed, run by Baylor College of Medicine. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058617, a Phase 1 study of Epstein-Barr Virus-Related Hodgkin Lymphoma and Epstein-Barr Virus-Related Non-Hodgkin Lymphoma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients 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 known for relapsed Lymphoma. Patients are being asked to volunteer to be in a research study using Epstein Barr virus 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 or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the 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. Investigators want to see if it's possible to grow special white blood cells, called T cells, that have been trained to kill EBV infected cells. Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.
Primary Outcome
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. The toxicity will be evaluated as per the NCI Common Toxicity criteria version 2.0.Any toxicity scored as Grade 3 or 4 according to this criteria will be classified as an adverse event. If no toxicity is observed in the first three patients then we will enroll another three patients at the next dose level. However, if t
Conditions Studied
Interventions
- BIOLOGICAL Injection of EBV Specific CTLs
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 1996-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT00058617 record still lists
NCT00058617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Epstein-Barr Virus-Related Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Injection of EBV Specific CTLs is the first listed.
NCT00058617 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00058617 about?
NCT00058617 is a clinical study titled "Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells, Relapsed Lymphoma, ANGEL". Patients 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 known for relapsed Lymphoma. Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotox...
What is the current status of trial NCT00058617?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 1996-01. Estimated completion is 2014-07.
What conditions does trial NCT00058617 study?
This clinical trial studies the following conditions: Epstein-Barr Virus-Related Hodgkin Lymphoma, Epstein-Barr Virus-Related Non-Hodgkin Lymphoma, EBV Positive Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00058617?
The interventions under investigation include: Injection of EBV Specific CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058617?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00058617 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00058617's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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