Trial Search Results

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fred Hutchinson Cancer Research Center

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Intervention(s):

  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
  • Drug: Atorvastatin Calcium
  • Procedure: Peripheral Blood Stem Cell Transplantation

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT referrals
650-723-0822
Not Recruiting