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NCT01005576 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01005576 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 21 participants.
The verdict
NCT01005576, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects. This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine, Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation. The primary hypothesis is that this regimen will promote stable engraftment of unrelated donor hematopoietic cells, support normal erythropoiesis, and result in an event free survival of \> 75% of children with thalassemia major.
Interventions
- DRUG Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01005576
The ClinicalTrials.gov registry entry for NCT01005576 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan is the first listed.
NCT01005576 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01005576 about?
NCT01005576 is a clinical study titled "Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia". This study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects. This study includes a preparative regimen with Hydrox...
What is the current status of trial NCT01005576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2010-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01005576?
The interventions under investigation include: Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan (DRUG).
Who is sponsoring clinical trial NCT01005576?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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