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NCT00840853 · ClinicalTrials.gov registry record · Phase 1
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
A Phase 1 study of Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia (CLL), sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT00840853 is a Phase 1 study of Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia (CLL) that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 68 participants, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00840853, a Phase 1 study of Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia (CLL), is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia or lymphoma, some people will relapse. In those who relapse, current treatment cures only a very small percentage. Although giving patients a dose of donor immune cells before relapse can prevent relapse of the leukemia or lymphoma, DLI can also cause a serious complication called graft versus host disease (GVHD). This is a gene transfer research study using special immune cells which are specific for these cancer cells. The body has different ways of fighting infection and disease. This study combines 2 of those ways, antibodies and T cells. T cells (CTLs or cytotoxic T cells) are infection-fighting blood cells that can kill cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but haven't been strong enough to cure most patients. The antibody used in this study is called anti-CD19. This antibody sticks to leukemia cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it's called a chimeric receptor. In the laboratory, investigators found that T cells that are trained to recognize common viruses can stay in the blood stream for many years. By joining the anti-CD19 antibody to CTLs that recognize viruses, they believe that they will also be able to make a cell that can last a long time in the body, provide protection from viruses, and recognize and kill leukemia. The CTLs which we will join the anti-CD19 antibody to attack 3 viruses (trivirus-specific CTLs), CMV, EBV, and adenovirus. Studies have shown that trivirus-specific CTLs grown from the stem cell donor can be given safely to transplant recip
Conditions Studied
Interventions
- GENETIC CD19CAR/virus specific T cells
- DRUG Benadryl and Tylenol
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-04 |
| Est. Completion | 2031-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00840853
The ClinicalTrials.gov registry entry for NCT00840853 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (69% 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 Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which CD19CAR/virus specific T cells is the first listed.
NCT00840853 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00840853 about?
NCT00840853 is a clinical study titled "Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT". Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia or lymphoma, some people will relapse. In those who relapse, current treatment cures only a very sm...
What is the current status of trial NCT00840853?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2009-04. Estimated completion is 2031-04.
What conditions does trial NCT00840853 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia (CLL), Acute Lymphoblastic Leukemia (ALL).
What interventions are being tested in trial NCT00840853?
The interventions under investigation include: CD19CAR/virus specific T cells (GENETIC), Benadryl and Tylenol (DRUG).
Who is sponsoring clinical trial NCT00840853?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00840853 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.