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NCT00001830 · ClinicalTrials.gov registry record · Phase 1
Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT00001830: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001830 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001830, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
Allogeneic peripheral blood stem cell transplantation (PBSCT) is primarily limited by graft-versus-host disease (GVHD). In murine models, we have demonstrated that donor CD4+ T cells of Th1 cytokine phenotype (defined by their secretion of IL-2 and IFN-gamma) mediate GVHD. In contrast, donor CD4+ T cells of Th2 phenotype (defined by their secretion of IL-4, IL-5, and IL-10) do not generate GVHD, and abrogate Th-1-mediated GVHD. Importantly, we have demonstrated that enrichment of murine allografts with Th2 cells reduces GVHD without impairing the ability of donor T cells to prevent graft rejection. These studies indicate that the administration of Th2 cells after allogeneic transplantation represents a strategy for achieving alloengraftment with reduced GVHD. In addition to GVHD, allogeneic PBSCT has been limited by the toxicity associated with conventional myeloablative preparative regimens. Such regimens, which typically utilize total body irradiation (TBI) and high-dose chemotherapy, were once considered essential for the prevention of graft rejection. However, recent clinical studies have shown that non-myeloablative doses of fludarabine-based chemotherapy can result in alloengraftment. In murine models, we have demonstrated that severe host T cell depletion induced by combination fludarabine and cytoxan can prevent even fully-MHC mismatched marrow graft rejection. Although non-myeloablative regimens may reduce regimen-related toxicity, such transplants have been associated with a 30 to 40% incidence of severe acute GVHD that is similar to rates observed with myeloablative regimens. Because non-myeloablative regimens appear to be associated with reduced regimen-related toxicity, we have elected to conduct this phase I study of Th2 cells in the setting of an immunoablative (non-myeloablative) preparative regimen. Patients with leukemia in clinical remission, and patients with refractory lymphoid malignancy will be candidates for this HLA-matched allogeneic PBSC
Interventions
- DRUG Th2 cells in allo HSCTT
- DRUG Th2 Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 1999-07-20 |
| Est. Completion | 2015-05-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001830
The ClinicalTrials.gov registry entry for NCT00001830 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 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 2 interventions - of which Th2 cells in allo HSCTT is the first listed.
NCT00001830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001830 about?
NCT00001830 is a clinical study titled "Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants". Allogeneic peripheral blood stem cell transplantation (PBSCT) is primarily limited by graft-versus-host disease (GVHD). In murine models, we have demonstrated that donor CD4+ T cells of Th1 cytokine phenotype (defined by their secretion of IL-2 and IFN-gamma) mediate GVHD. In contrast, donor CD4+ T ...
What is the current status of trial NCT00001830?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 1999-07-20. Estimated completion is 2015-05-19.
What interventions are being tested in trial NCT00001830?
The interventions under investigation include: Th2 cells in allo HSCTT (DRUG), Th2 Cells (DRUG).
Who is sponsoring clinical trial NCT00001830?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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