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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 is a Phase 3 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 87 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00075478
The ClinicalTrials.gov registry entry for NCT00075478 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00075478 reports 0 study locations.
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.
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