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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: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00303667 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients alive without evidence of disease at 6 months after transplant
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 |
What the finished NCT00303667 record still lists
NCT00303667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00303667 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00303667's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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