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NCT00160355 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Hematopoietic Stem Cell Transplantation Patients With Wiskott-Aldrich Syndrome
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00160355 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 4 participants.
The verdict
NCT00160355, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Wiskott - Aldrich syndrome (WAS) is a rare disorder curable only through allogeneic hematopoietic stem cell transplantation. A mismatched family member is an option when no human leukocyte antigen (HLA-immune system type) matched related or matched unrelated donor is available. This study will evaluate a novel therapeutic strategy for patients with WAS who undergo haploidentical transplantation using a parental donor. To reduce the risk of transplant-related toxicities, participants will receive a reduced intensity chemotherapy and antibody regimen (conditioning treatment). Participants will then receive an infusion of donor stem cells depleted of certain white blood cells called T- and B-lymphocytes. The stem cell depletion processing will be done through the use of the investigational CliniMACS device. A certain number of T-lymphocytes will be added back to the processed stem cell graft prior to infusion into the recipient. The primary objective of this study is to determine the safety of haploidentical transplantation in WAS patients using this specified conditioning regimen and engineered graft. Safety will be defined in terms of engraftment (meaning how well the graft grows and functions after infusion) and regimen-related toxicity within the first 100 days after transplant.
Interventions
- PROCEDURE Hematopoietic stem cell transplantation
- DEVICE Miltenyi CliniMACS selection system
- DRUG Fludarabine, Melphalan, Thiotepa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00160355
The ClinicalTrials.gov registry entry for NCT00160355 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 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 Hematopoietic stem cell transplantation is the first listed.
NCT00160355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00160355 about?
NCT00160355 is a clinical study titled "Haploidentical Hematopoietic Stem Cell Transplantation Patients With Wiskott-Aldrich Syndrome". Wiskott - Aldrich syndrome (WAS) is a rare disorder curable only through allogeneic hematopoietic stem cell transplantation. A mismatched family member is an option when no human leukocyte antigen (HLA-immune system type) matched related or matched unrelated donor is available. This study will eval...
What is the current status of trial NCT00160355?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2005-05. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00160355?
The interventions under investigation include: Hematopoietic stem cell transplantation (PROCEDURE), Miltenyi CliniMACS selection system (DEVICE), Fludarabine, Melphalan, Thiotepa (DRUG).
Who is sponsoring clinical trial NCT00160355?
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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