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NCT00448357 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00448357: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00448357 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00448357, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before the transplant and tacrolimus after the transplant may stop this from happening. PURPOSE: The phase I portion of this trial identified the maximum tolerated dose of busulfan after treating 40 patients on a dose-escalation scheme. We are now treating an additional 26 patients on the phase II portion of the trial at a Pharmacokinetic (PK)-directed dose of total area under curve (AUC) 6912 micrometer (uM)-min/24 hours. We transitioned to the Phase II portion of the study in October 2009.
Primary Outcome
Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG busulfan
- BIOLOGICAL therapeutic allogeneic lymphocytes
- BIOLOGICAL rabbit anti-thymocyte globulin (ATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2005-10 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT00448357 record still lists
NCT00448357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00448357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00448357 about?
NCT00448357 is a clinical study titled "Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen". RATIONALE: Giving chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infus...
What is the current status of trial NCT00448357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2005-10. Estimated completion is 2015-11.
What interventions are being tested in trial NCT00448357?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), busulfan (DRUG), therapeutic allogeneic lymphocytes (BIOLOGICAL), rabbit anti-thymocyte globulin (ATG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00448357?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00448357's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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