drugset / Trial / NCT01527045

Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies

NCT01527045

NaSingle-groupOpen-labelPrevention

Summary

This phase II trial studies how well donor atorvastatin treatment works in preventing severe graft-versus-host disease (GVHD) after nonmyeloablative peripheral blood stem cell (PBSC) transplant in patients with hematological malignancies. Giving low doses of chemotherapy, such as fludarabine phosphate, before a donor PBSC transplantation slows the growth of cancer cells and may also prevent the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also cause an immune response against the body's normal cells (GVHD). Giving atorvastatin to the donor before transplant may prevent severe GVHD.

Timeline

Start
2012-09-25
Primary completion
2018-10
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule Oral
Background Cyclosporine Peptide Oral
Background Fludarabine Small molecule Intravenous
Background Mycophenolate Mofetil Small molecule Oral