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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: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01005576 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01005576 record still lists
NCT01005576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01005576's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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