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 |
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.
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.
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
1100 Fairview Avenue North
Seattle, Washington 98109
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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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
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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900 Quarry Road Extension
Stanford, California 94305
Stanford, California 94305
(650) 723-5111
Stanford University Hospitals and Clinics A LEADER IN THE BIOMEDICAL REVOLUTION , Stanford Medicine has...
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