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NCT00361140 · ClinicalTrials.gov registry record · Phase 4
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
A Phase 4 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT00361140: Completed Phase 4 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00361140 is a Phase 4 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361140, a Phase 4 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study Summary
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell reinfusion. Supportive care will be based on institutional guidelines. Blood samples will be collected for dose modification based on the AUC levels. Dose escalation will proceed to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan.
Primary Outcome
The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT00361140 record still lists
NCT00361140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT00361140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361140 about?
NCT00361140 is a clinical study titled "Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)". Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve (AUC). Day 0 is the day of hematopoietic progenitor cell reinfusion. Supportive care wi...
What is the current status of trial NCT00361140?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2005-08. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00361140?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG).
Who is sponsoring clinical trial NCT00361140?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361140's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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