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NCT00789776 · ClinicalTrials.gov registry record · Phase 1
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00789776 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 41 participants.
The verdict
NCT00789776, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of donor natural killer (NK) cell therapy and to see how well it works when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate mofetil, and tacrolimus in treating patients with hematologic cancer. Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting 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. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and tacrolimus after the transplant may stop 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 | 41 participants |
| Start Date | 2008-10-13 |
| Est. Completion | 2017-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00789776
The ClinicalTrials.gov registry entry for NCT00789776 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 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.
NCT00789776 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00789776 about?
NCT00789776 is a clinical study titled "Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer". This phase I/II trial studies the side effects and best dose of donor natural killer (NK) cell therapy and to see how well it works when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate mofetil, and tacrolimus in treatin...
What is the current status of trial NCT00789776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2008-10-13. Estimated completion is 2017-05.
What interventions are being tested in trial NCT00789776?
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 NCT00789776?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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