Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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