Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
Completed · Phase 2
Conditions studied: Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT01525407
- Run by
- Fred Hutchinson Cancer Center
- People needed
- 83
- Starts
- 2012-05-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Human leukocyte antigen (HLA)-identical sibling donor
- Myeloablative preparative regimen (i.e., >= TBI 12.0 Gy, >= busulfan (BU) 8.0 mg/kg PO, >= BU 6.4 mg/kg intravenously (IV), >= treosulfan 42 g/m\^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
- Transplantation of PBSC
- Cyclosporine (CSP)-based postgrafting immunosuppression
- Willingness to give informed consent
- DONOR: Age >= 18 years
- DONOR: HLA genotypically identical sibling
- DONOR: Willingness to give informed consent
You may not qualify if…
- Nonmyeloablative preparative regimen
- Participation in an investigational study that has acute GVHD as the primary endpoint
- The allogeneic PBSC donor has a contraindication to statin treatment
- DONOR: Age < 18 years
- DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])
- DONOR: History of myopathy
- DONOR: Hypersensitivity to atorvastatin
- DONOR: Pregnancy
- DONOR: Nursing mother
- DONOR: Current serious systemic illness
- DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
- DONOR: Current use of statin drug
- DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
- DONOR: Total creatinine kinase > 2 times the ULN
Where it is running
- Stanford University Hospitals and Clinics — Stanford, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.