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NCT00556452 · ClinicalTrials.gov registry record · Phase 1
Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00556452: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00556452 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00556452, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.
Primary Outcome
The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).
Interventions
- DRUG Clofarabine/Busulfan x 4
- PROCEDURE Peripheral blood stem cell transplant
- RADIATION Total Lymphoid Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2007-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT00556452 record still lists
NCT00556452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Clofarabine/Busulfan x 4 is the first listed.
NCT00556452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00556452 about?
NCT00556452 is a clinical study titled "Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen". The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in th...
What is the current status of trial NCT00556452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2007-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00556452?
The interventions under investigation include: Clofarabine/Busulfan x 4 (DRUG), Peripheral blood stem cell transplant (PROCEDURE), Total Lymphoid Irradiation (RADIATION).
Who is sponsoring clinical trial NCT00556452?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00556452's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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