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NCT00968760 · ClinicalTrials.gov registry record · Phase 1
CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00968760: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00968760 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00968760, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells. The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body. Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.
Interventions
- DRUG IL-2
- PROCEDURE Leukapheresis
- DRUG Carmustine
- PROCEDURE Stem Cell Transplant
- PROCEDURE CD19-specific T Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-06-20 |
| Est. Completion | 2020-04-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00968760
The ClinicalTrials.gov registry entry for NCT00968760 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which IL-2 is the first listed.
NCT00968760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00968760 about?
NCT00968760 is a clinical study titled "CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies". Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then ...
What is the current status of trial NCT00968760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-06-20. Estimated completion is 2020-04-23.
What interventions are being tested in trial NCT00968760?
The interventions under investigation include: IL-2 (DRUG), Leukapheresis (PROCEDURE), Carmustine (DRUG), Stem Cell Transplant (PROCEDURE), CD19-specific T Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00968760?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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