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NCT00058786 · ClinicalTrials.gov registry record · Phase 1
Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00058786 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 9 participants.
The verdict
NCT00058786, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a research study to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patient. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which preclinical human and animal studies suggest will help IL-2 perform better. Some of these cells will then be put back into the body. The cells are grown with normal embryonic fibroblasts. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. The purpose of this study is to learn the side effects and the safest effective dose of these special cells on the disease
Interventions
- BIOLOGICAL Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2002-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058786
The ClinicalTrials.gov registry entry for NCT00058786 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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 1 intervention - of which Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells is the first listed.
NCT00058786 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00058786 about?
NCT00058786 is a clinical study titled "Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells". This is a research study to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patient. This will be done in the laboratory. This gene will make the cel...
What is the current status of trial NCT00058786?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2002-12. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00058786?
The interventions under investigation include: Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058786?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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