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



Status:Completed
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Infectious Disease, Lymphoma, Women's Studies, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012

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Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

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.

PRIMARY OBJECTIVES:

I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute
GVHD.

SECONDARY OBJECTIVES:

I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible,
tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last
day of stem cell collection.

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
We found this trial at
3
sites
900 Quarry Road Extension
Stanford, California 94305
(650) 723-5111
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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Stanford, CA
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1100 Fairview Avenue North
Seattle, Washington 98109
206-667-4584
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium The Fred Hutchinson/University of Washington Cancer...
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Seattle, WA
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, CO
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