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NCT00397813 · ClinicalTrials.gov registry record · Phase 2
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT00397813 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 77 participants.
The verdict
NCT00397813, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops 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 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 the transplant may stop this from happening.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- DRUG Cyclosporine
- PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2006-01 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00397813
The ClinicalTrials.gov registry entry for NCT00397813 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 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 Laboratory Biomarker Analysis is the first listed.
NCT00397813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00397813 about?
NCT00397813 is a clinical study titled "Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders". This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). Giving low doses of...
What is the current status of trial NCT00397813?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2006-01. Estimated completion is 2018-03.
What interventions are being tested in trial NCT00397813?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Cyclosporine (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00397813?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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