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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
83
Undergo myeloablative allogeneic PBSC transplant
Given PO
Undergo myeloablative allogeneic PBSC transplant
Stanford University Hospitals and Clinics
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Grade 3-4 Acute GVHD
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
Time frame: First 100 days after transplant
Chronic Extensive GVHD
Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.
Time frame: 2 years post transplant
Disease-free Survival
Evaluated as Kaplan-Meier estimate in the patients/recipients.
Time frame: 1 year after transplant
Grades II-IV Acute GVHD
Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.
Time frame: First 100 days after transplant
Non-relapse Mortality
Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.
Time frame: At day 100
Non-relapse Mortality
Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.
Time frame: At 1 year after HCT
Overall Survival
Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.
Time frame: 1 year after transplant
Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity
Time frame: Until completion of stem cell collection (on average 14 days)
Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Time frame: First 100 days after transplant
Recurrent or Progressive Malignancy
Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.
Time frame: Up to 3 years
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