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NCT00368082 · ClinicalTrials.gov registry record · Phase 1
Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)
A Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 2
- Study locations
NCT00368082 is a Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 8 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00368082, a Phase 1 study of Lymphoma and Lymphoma, Non-Hodgkin, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3 diseases will be referred to as "Lymphoma"). The lymphoma has come back or has not gone away after treatment. This is a research study using special immune system cells called TGFb-resistant LMP-specific cytotoxic T lymphocytes (DNR-CTL), a new experimental therapy. Some patients with Lymphoma show signs of infection with the Epstein Barr virus (EBV) before or at the time of their Lymphoma diagnosis. EBV is found in the cancer cells of up to 1/2 the patients with Lymphoma, suggesting 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 being killed by releasing a substance called Transforming Growth Factor-beta (TGFb). The investigators want to see if special white blood cells (called T cells) that have been given a gene that they hope will let them survive against TGFb and that have been trained to kill EBV infected cells can also survive in the blood and kill the tumor. Investigators have used this sort of therapy with specially trained T cells to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this type of cancer they were able to successfully prevent and treat post transplant lymphoma. However when they used a similar approach in HD some patients had a partial response to this therapy, but no patients had a complete response. In a follow-up study they tried to find out if they could improve this treatment by growing T cells that recognize 2 of the proteins expressed on Lymphoma cells called LMP-1 and LMP2a. These special T cells were called LMP-specific cytotoxic T-lymphocytes (CTLs). Although some patients had tumor responses, CTL therapy alone did not cure those who had a lot of disease. Investigators think that a reason for this is that the tumor cells are releasing TGFb. For this reason, they want to find out if they
Conditions Studied
Interventions
- BIOLOGICAL TGFbeta resistant LMP-specific CTLs
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Childrens Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2006-04 |
| Est. Completion | 2031-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00368082
The ClinicalTrials.gov registry entry for NCT00368082 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (98% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which TGFbeta resistant LMP-specific CTLs is the first listed.
NCT00368082 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00368082 about?
NCT00368082 is a clinical study titled "Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)". Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3 diseases will be referred to as "Lymphoma"). The lymphoma has come back or has not gone away after treatment. This is a research study using special immune system cells called TGFb-resistant LMP-specific cytotoxi...
What is the current status of trial NCT00368082?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2006-04. Estimated completion is 2031-07.
What conditions does trial NCT00368082 study?
This clinical trial studies the following conditions: Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin's Disease, Relapse.
What interventions are being tested in trial NCT00368082?
The interventions under investigation include: TGFbeta resistant LMP-specific CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00368082?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00368082 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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