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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 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.
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.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2005-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361140
The ClinicalTrials.gov registry entry for NCT00361140 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT00361140 reports 0 study locations.
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.
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