NCT01525407

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo myeloablative allogeneic PBSC transplant
DRUG	Atorvastatin Calcium	Given PO
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo myeloablative allogeneic PBSC transplant

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-09-01
• Completion: 2016-02-01
• First posted: 2012-02-03
• Last updated: 2017-08-17
• Results posted: 2017-08-17

Locations

3 sites across 1 country: United States