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NCT01048827 · ClinicalTrials.gov registry record · Phase 1
Targeted, Dose-Escalation Busulfan-Etoposide as Prep Regimen
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01048827 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 12 participants.
The verdict
NCT01048827, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over this period and together with collaborative transplant centers, over 200 patients have received this treatment. By intent-to-treat analysis, and with median follow-up of 7.0 years, the 5-year DFS is 55%. The current protocol will utilize the combination of IV Busulfan (BU) and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels. All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing, with the lowest dose being approximately 14% higher than standard. Busulfan levels will be monitored after the first, fourth and twelfth doses. Dose adjustments will be made "in real time" based on AUC levels determined from the first and fourth doses. This strategy of busulfan monitoring and dose adjustment has improved the therapeutic widow of BU in previous clinical trials. The current protocol will utilize the combination of intravenous busulfan and etoposide. The busulfan dose will be escalated amongst 3 targeted dose levels (area under the curve (AUC) levels at time 6 hours of 1250 uMol\*min, 1400 uMol\*min and 1550 uMol\*min). All targeted dose levels represent higher busulfan dosing than standard myeloablative dosing with the lowest dose (1250 uMol\*min) being approximately 14% higher than standard. In the absence of dose-limiting toxicity, cohorts of 4-6 patients will be treated at each dose level and 10 additional patients will be treated at the maximum tolerated dose (MTD) to confirm safety. The busulfan dosing will begin at 1 mg/kg based on historical plasma levels obtained from patients receiving BU at a starting dose of 0.8 mg/kg at UCSF Medical Center. The highest dose level proposed for this study will exceed the reported toxic level for busulfan in the alloSCT setting. Patients will be followed closely for toxicity and strict stoppi
Interventions
- DRUG Busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-11 |
| Est. Completion | 2015-02-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01048827
The ClinicalTrials.gov registry entry for NCT01048827 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Busulfan is the first listed.
NCT01048827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01048827 about?
NCT01048827 is a clinical study titled "Targeted, Dose-Escalation Busulfan-Etoposide as Prep Regimen". Busulfan and etoposide have been used as preparative therapy for autoSCT (stem cell transplant) in adults with acute myeloid leukemia (AML) at UCSF for the past 10 years. Over this period and together with collaborative transplant centers, over 200 patients have received this treatment. By intent-to...
What is the current status of trial NCT01048827?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-11. Estimated completion is 2015-02-25.
What interventions are being tested in trial NCT01048827?
The interventions under investigation include: Busulfan (DRUG).
Who is sponsoring clinical trial NCT01048827?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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