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NCT00075478 · ClinicalTrials.gov registry record · Phase 3
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
A Phase 3 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT00075478: Completed Phase 3 study, sponsored by Fred Hutchinson Cancer Center.
NCT00075478 is a Phase 3 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00075478, a Phase 3 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer.
Primary Outcome
Percentage of patients surviving as estimated by Kaplan-Meier.
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- DRUG Cyclosporine
- PROCEDURE Total-Body Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2003-10 |
| Est. Completion | 2014-02-02 |
| Phase | Phase 3 |
What the finished NCT00075478 record still lists
NCT00075478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00075478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00075478 about?
NCT00075478 is a clinical study titled "Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer". This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and rad...
What is the current status of trial NCT00075478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2003-10. Estimated completion is 2014-02-02.
What interventions are being tested in trial NCT00075478?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Cyclosporine (DRUG), Total-Body Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT00075478?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00075478's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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