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

Trial ID or NCT#

NCT01525407

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Andrew Rezvani, M.D.
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Robert Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

CONTACT

BMT Referrals
(650) 723-0822