Conditions: Malignant Neoplasm
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.

Interventions: intervention 1: Allogeneic Hematopoietic Stem Cell Transplantation intervention 2: Atorvastatin Calcium intervention 3: Peripheral Blood Stem Cell Transplantation
Intervention descriptions: intervention 1: Undergo myeloablative allogeneic PBSC transplant intervention 2: Given PO intervention 3: Undergo myeloablative allogeneic PBSC transplant

Protocol document: