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NCT01087294 · ClinicalTrials.gov registry record · Phase 1
Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT01087294: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01087294 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087294, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
Background: * Allogeneic hematopoietic stem cell transplantation (alloHSCT) is a procedure that transplants bone marrow cells (stem cells) from a matching donor into a recipient in order to allow the donor stem cells to produce cells that will attack the recipient s cancer cells. AlloHSCT is performed when chemotherapy, immunotherapy, or radiation therapy do not adequately control cancer growth. However, cancers that are not controlled by alloHSCT frequently become resistant to other standard treatment options. * The outcomes of alloHSCT might be improved if certain kinds of white blood cells (T cells) could be manipulated so that they generate a more potent effect against the cancer cells. This effect can be augmented by genetically engineering donor T cells to specifically recognize cancerous cells in order to attack them. For this purpose, researchers are studying a specific kind of genetically engineered T cell known as the anti-CD19-CAR-transduced T cell. More research is needed to determine if this T cell will be an effective treatment for certain kinds of B cell cancer (such as non-Hodgkin s lymphoma and chronic lymphocytic leukemia) that has not been controlled with alloHSCT. Objectives: \- To assess the safety and effectiveness of administering allogeneic anti-CD19-CAR-transduced T cells to patients with B-cell cancer that has not responded to alloHSCT. Eligibility: * Individuals between 18 and 75 years of age who have received allogeneic hematopoietic stem cell transplantation for a B cell cancer, but whose cancer has either not responded to or recurred after the transplant. * Recipients must have the same stem cell donor from their previous procedure. Design: * Before the start of the study, all participants will be screened with a medical history and blood tests. Recipients will have tumor imaging scans, additional blood tests, and other tests as directed by the study doctors. * Donor participants will undergo apheresis to provide white blood cell
Interventions
- PROCEDURE Leukapheresis
- PROCEDURE Allogeneic stem cell transplant
- BIOLOGICAL Anti-CD19-chimeric-antigen-receptor-transduced T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2010-08-04 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01087294
The ClinicalTrials.gov registry entry for NCT01087294 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leukapheresis is the first listed.
NCT01087294 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01087294 about?
NCT01087294 is a clinical study titled "Administration of Anti-CD19-chimeric-antigen-receptor-transduced T Cells From the Original Transplant Donor to Patients With Recurrent or Persistent B-cell Malignancies After Allogeneic Stem Cell Transplantation". Background: * Allogeneic hematopoietic stem cell transplantation (alloHSCT) is a procedure that transplants bone marrow cells (stem cells) from a matching donor into a recipient in order to allow the donor stem cells to produce cells that will attack the recipient s cancer cells. AlloHSCT is perfor...
What is the current status of trial NCT01087294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2010-08-04. Estimated completion is 2024-04-02.
What interventions are being tested in trial NCT01087294?
The interventions under investigation include: Leukapheresis (PROCEDURE), Allogeneic stem cell transplant (PROCEDURE), Anti-CD19-chimeric-antigen-receptor-transduced T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01087294?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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