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NCT00586391 · ClinicalTrials.gov registry record · Phase 1
CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL
A Phase 1 study of Chronic Lymphocytic Leukemia and B-cell Lymphoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT00586391 is a Phase 1 study of Chronic Lymphocytic Leukemia and B-cell Lymphoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 14 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00586391, a Phase 1 study of Chronic Lymphocytic Leukemia and B-cell Lymphoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "Lymphoma" or "Leukemia"). Their Lymphoma or Leukemia has come back or has not gone away after treatment (including the best treatment known for these cancers). This research study is a gene transfer study using special immune cells. The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to cancer cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and Leukemia. For this study anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, investigators have also found that T cells work better if they also put a protein that stimulates T cells called CD28. Investigators hope that adding the CD28 might also make the cells last for
Conditions Studied
Interventions
- DRUG Ipilimumab
- GENETIC CD19CAR-28-zeta T cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-02 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00586391
The ClinicalTrials.gov registry entry for NCT00586391 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (92% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT00586391 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00586391 about?
NCT00586391 is a clinical study titled "CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL". Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "Lymphoma" or "Leukemia"). Their Lymphoma or Leukemia has come back or has not gone away after treatment (including...
What is the current status of trial NCT00586391?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2009-02. Estimated completion is 2029-07.
What conditions does trial NCT00586391 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, B-cell Lymphoma, Acute Lymphocytic Leukemia.
What interventions are being tested in trial NCT00586391?
The interventions under investigation include: Ipilimumab (DRUG), CD19CAR-28-zeta T cells (GENETIC).
Who is sponsoring clinical trial NCT00586391?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00586391 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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