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NCT00448201 · ClinicalTrials.gov registry record · Phase 2
Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT00448201: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00448201 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00448201, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Immunosuppressive therapy may improve bone marrow function and may be an effective treatment for hematologic cancer or other disease. PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and fludarabine with or without antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer or other disease.
Primary Outcome
Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.
Interventions
- DRUG fludarabine phosphate
- DRUG busulfan
- BIOLOGICAL anti-thymocyte globulin
- BIOLOGICAL sargramostim
- BIOLOGICAL therapeutic allogeneic lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2011-01-07 |
| Est. Completion | 2012-05-23 |
| Phase | Phase 2 |
What the finished NCT00448201 record still lists
NCT00448201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00448201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00448201 about?
NCT00448201 is a clinical study titled "Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease". RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient'...
What is the current status of trial NCT00448201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2011-01-07. Estimated completion is 2012-05-23.
What interventions are being tested in trial NCT00448201?
The interventions under investigation include: fludarabine phosphate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL), sargramostim (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00448201?
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 NCT00448201's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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