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NCT00143559 · ClinicalTrials.gov registry record · Phase 2
Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00143559 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 17 participants.
The verdict
NCT00143559, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection. For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality. Two groups of patients were enrolled on this study. One group included those with high-risk hematologic malignancies and the second group included participants with refractory hematologic malignancies or undergoing a second transplant. The primary aim of the study was to estimate the relapse rate in the one group of research participants with refractory hematologic malignanci
Interventions
- PROCEDURE Allogeneic stem cell transplantation
- DEVICE Miltenyi CliniMACS
- DRUG Systematic chemotherapy and antibodies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00143559
The ClinicalTrials.gov registry entry for NCT00143559 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Allogeneic stem cell transplantation is the first listed.
NCT00143559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00143559 about?
NCT00143559 is a clinical study titled "Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies". Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the...
What is the current status of trial NCT00143559?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2005-08. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00143559?
The interventions under investigation include: Allogeneic stem cell transplantation (PROCEDURE), Miltenyi CliniMACS (DEVICE), Systematic chemotherapy and antibodies (DRUG).
Who is sponsoring clinical trial NCT00143559?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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