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NCT00358657 · ClinicalTrials.gov registry record · Phase 2
Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited Disorders
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00358657 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 14 participants.
The verdict
NCT00358657, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects of fludarabine phosphate, cyclophosphamide and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide, mycophenolate mofetil, tacrolimus, and sirolimus in treating patients with primary immunodeficiency disorders or noncancerous inherited disorders. Giving low doses of chemotherapy and total-body irradiation before a bone marrow transplant helps prepare the patient's body to accept the incoming donor's bone marrow and decrease the risk that the patient's immune system will reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, tacrolimus, and sirolimus after the transplant may help decrease this from happening.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Bone Marrow Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-05-24 |
| Est. Completion | 2019-05-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358657
The ClinicalTrials.gov registry entry for NCT00358657 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 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 Cyclophosphamide is the first listed.
NCT00358657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00358657 about?
NCT00358657 is a clinical study titled "Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited Disorders". This phase I/II trial studies the side effects of fludarabine phosphate, cyclophosphamide and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide, mycophenolate mofetil, tacrolimus, and sirolimus in treating patients with primary immunodeficiency disorders or noncanc...
What is the current status of trial NCT00358657?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2006-05-24. Estimated completion is 2019-05-25.
What interventions are being tested in trial NCT00358657?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Allogeneic Bone Marrow Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00358657?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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