Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation; Atorvastatin Calcium; Peripheral Blood Stem Cell Transplantation
Intervention description: Undergo myeloablative allogeneic PBSC transplant; Given PO; Undergo myeloablative allogeneic PBSC transplant
Intervention MeSH terms: Atorvastatin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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