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

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
Phase       II

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Research Study Description

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 (must meet the following to participate in this study)

Genders Eligible for Study: Both

- 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)

- 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

Other exclusion criteria may apply.

Research Study Number       2545.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

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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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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