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NCT00119340 · ClinicalTrials.gov registry record · Phase 1
Fludarabine, Total-Body Irradiation, and Donor Stem Cell Transplant Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Chronic Myelogenous Leukemia
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00119340 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 75 participants.
The verdict
NCT00119340, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, 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 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. PURPOSE: This phase I/II trial is studying the side effects and best dose of fludarabine, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil and to see how well they work in treating patients with chronic myelogenous leukemia.
Interventions
- DRUG fludarabine phosphate
- RADIATION radiation therapy
- PROCEDURE peripheral blood stem cell transplantation
- DRUG cyclosporine
- DRUG mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00119340
The ClinicalTrials.gov registry entry for NCT00119340 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 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 fludarabine phosphate is the first listed.
NCT00119340 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00119340 about?
NCT00119340 is a clinical study titled "Fludarabine, Total-Body Irradiation, and Donor Stem Cell Transplant Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Chronic Myelogenous Leukemia". RATIONALE: Giving low doses of chemotherapy, such as fludarabine, 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 ...
What is the current status of trial NCT00119340?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2005-04. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00119340?
The interventions under investigation include: fludarabine phosphate (DRUG), radiation therapy (RADIATION), peripheral blood stem cell transplantation (PROCEDURE), cyclosporine (DRUG), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00119340?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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