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Complete title: Donor Statin Treatment for Prevention of Severe Acute GVHD after Myeloablative Hematopoietic Cell Transplantation
|Research Study Number||2545.00|
|Principal Investigator||Marco Mielcarek, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
Leukemia, Acute Myeloid (AML); Breast Cancer; Lymphoma, Burkitt's; Hematologic Malignancies; Lymphoma, Hodgkin; Leukemia; Lymphoma; Multiple Myeloma (MM); Lymphoma, Non-Hodgkin (NHL); Solid Tumors
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