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NCT01525407 · ClinicalTrials.gov registry record · Phase 2
Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT01525407: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01525407 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525407, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system 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. Giving atorvastatin to the donor before transplant may prevent this from happening.
Primary Outcome
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
Interventions
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Atorvastatin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01525407 record still lists
NCT01525407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Peripheral Blood Stem Cell Transplantation is the first listed.
NCT01525407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525407 about?
NCT01525407 is a clinical study titled "Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation". This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant hel...
What is the current status of trial NCT01525407?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2012-05. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01525407?
The interventions under investigation include: Peripheral Blood Stem Cell Transplantation (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Atorvastatin Calcium (DRUG).
Who is sponsoring clinical trial NCT01525407?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525407's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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