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NCT00458679 · ClinicalTrials.gov registry record · Phase 1
Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells
A Phase 1 study of Chronic Lymphocytic Leukemia (CLL), sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT00458679: Completed Phase 1 study of Chronic Lymphocytic Leukemia (CLL), sponsored by Baylor College of Medicine.
NCT00458679 is a Phase 1 study of Chronic Lymphocytic Leukemia (CLL) that has completed, run by Baylor College of Medicine. The registered enrollment target is 6 participants, below the 191-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458679, a Phase 1 study of Chronic Lymphocytic Leukemia (CLL), has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
We would like patients to be in a research study to determine the safety and effectiveness of special cells that may make their own immune system fight their cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. 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 their immune system kill cancer cells. Additionally, we will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Studies of cancers in animals suggest IL-2 performs better when mixed with CD40L. Some of these cells will then be put back into the patients body with the goal that they will act like a vaccine and stimulate their immune system to attack the CLL cells. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer cells. We have already conducted a study similar to this in patients with CLL. In that study, the subjects received about three months of injections (shots). In those subjects we saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. In this study we want to see if we can make the change in the immune system last longer by giving more injections over a longer period of time. We hope that this might produce a better response directed at the CLL cells. We will also be looking at the effect on cells called cancer stem cells which grow into the CLL cells we see in the blood. Specifically, this study will allow subjects to receive the injections for up to one year.
Conditions Studied
Interventions
- BIOLOGICAL CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE
Study Locations (1)
Texas
- The Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT00458679 record still lists
NCT00458679 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 191-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 1 intervention - of which CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE is the first listed.
NCT00458679 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00458679 about?
NCT00458679 is a clinical study titled "Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells". We would like patients to be in a research study to determine the safety and effectiveness of special cells that may make their own immune system fight their cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. This will be done in the labora...
What is the current status of trial NCT00458679?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-12. Estimated completion is 2013-08.
What conditions does trial NCT00458679 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL).
What interventions are being tested in trial NCT00458679?
The interventions under investigation include: CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE (BIOLOGICAL).
Who is sponsoring clinical trial NCT00458679?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00458679 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia (CLL)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00458679's enrollment target sits among peer trials
6 30th of 29 the lowest of 29 other Chronic Lymphocytic Leukemia (CLL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia (CLL) 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.
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