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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 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 6 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00383097
The ClinicalTrials.gov registry entry for NCT00383097 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LMP1 SPECIFIC CYTOTOXIC T-LYMPHOCYTES is the first listed.
NCT00383097 reports 0 study locations.
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.
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