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NCT03513328 · ClinicalTrials.gov registry record · Phase 1
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03513328: Completed Phase 1 study, sponsored by University of Florida.
NCT03513328 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513328, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.
Primary Outcome
Assess the MED of thiotepa in combination with reduced-dose busulfan, fludarabine and rATG required to achieve engraftment in \>90% subjects undergoing hematopoietic stem cell transplantation for non-malignant disorders.
Interventions
- DRUG Thiotepa--single daily dose
- DRUG Thiotepa--escalated dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2023-02-19 |
| Phase | Phase 1 |
What the finished NCT03513328 record still lists
NCT03513328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Thiotepa--single daily dose is the first listed.
NCT03513328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03513328 about?
NCT03513328 is a clinical study titled "Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation". In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing h...
What is the current status of trial NCT03513328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-06-15. Estimated completion is 2023-02-19.
What interventions are being tested in trial NCT03513328?
The interventions under investigation include: Thiotepa--single daily dose (DRUG), Thiotepa--escalated dose (DRUG).
Who is sponsoring clinical trial NCT03513328?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03513328's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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