Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fred Hutchinson Cancer Center
With
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
PRIMARY OBJECTIVES:
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.
SECONDARY OBJECTIVES:
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.
OUTLINE:
Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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
Clareo Health | Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
