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NCT00303667 · ClinicalTrials.gov registry record · Phase 1
Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00303667 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 50 participants.
The verdict
NCT00303667, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total body irradiation, before peripheral blood stem cell 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 and natural killer (NK) 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 IL-2 (aldesleukin) after NK cell infusion may stimulate them to kill any remaining cancer cells. PURPOSE: This phase I/II (currently enrolling in phase II) trial is studying how well a donor natural killer cell infusion works in treating patients who are undergoing donor stem cell transplant for acute myeloid leukemia.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- BIOLOGICAL aldesleukin
- BIOLOGICAL natural killer cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00303667
The ClinicalTrials.gov registry entry for NCT00303667 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00303667 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00303667 about?
NCT00303667 is a clinical study titled "Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant". RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total body irradiation, before peripheral blood stem cell 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 ste...
What is the current status of trial NCT00303667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-01. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00303667?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), aldesleukin (BIOLOGICAL), natural killer cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00303667?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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