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NCT00383097 · ClinicalTrials.gov registry record · Phase 1
Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00383097: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT00383097 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383097, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory. If we are successful in growing these cells and if we feel they would be helpful to the donor, we would then give the cells back to the donor. This trial is for patients that have a type of lymph gland cancer called Hodgkin or non-Hodgkin lymphoma, or chronic active Epstein Barr virus (EBV) infection, which has come back or not gone away after treatment, including the best treatment we know. This is a research study using special immune system cells called LMP1- and LMP2-specific cytotoxic T lymphocytes (LMP1- and LMP2-CTLs), a new experimental therapy. As in chronic active EBV infection, some patients with Hodgkin or non-Hodgkin lymphoma show evidence of infection with the virus that causes infectious mononucleosis (EBV) before or at the time of their diagnosis of the Lymphoma. EBV is found in the cancer cells of up to half the patients with lymphoma, suggesting that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill EBV infected cells can survive in the patient's blood and affect EBV-positive cells. In this present study we are trying to find out if we can improve this treatment by growing T cells that only recognize two of the proteins expressed on lymphoma cells called LMP1 and LMP2. These special T cells are called LMP1- and LMP2-specific cytotoxic CTLs.
Interventions
- GENETIC LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES
- GENETIC LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
Why NCT00383097 stopped before completion
NCT00383097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES is the first listed.
NCT00383097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00383097 about?
NCT00383097 is a clinical study titled "Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma". The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that they are able to attack LMP1- and LMP2-positive cells in the laboratory. If we are successful in gr...
What is the current status of trial NCT00383097?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-09. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00383097?
The interventions under investigation include: LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES (GENETIC), LMP2-SPECIFIC CYTOTOXIC T-LYMPHOCYTES (GENETIC).
Who is sponsoring clinical trial NCT00383097?
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 NCT00383097's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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