Clinical Trial Detail

This clinical 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

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

- 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

- 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

Other eligibility criteria may apply.

- 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) criteria for stem cell donation

Other exclusion criteria may apply.