CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Atorvastatin Calcium +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01525407
NCT01525407Phase 2Completed
CompareCT.gov

Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

Fred Hutchinson Cancer Center·interventional·Posted Feb 3, 2012·Updated Aug 17, 2017

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Atorvastatin Calcium, and 1 other intervention for Malignant Neoplasm. Completed, enrolled 83 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.4 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo myeloablative allogeneic PBSC transplant

Atorvastatin Calciumdrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo myeloablative allogeneic PBSC transplant