Evaluation of progenitor cell mobilizing effect of atorvastatin in autologous hematopoietic stem cell transplantation

1. Objectives Evaluation of hematopoietic progenitor cell mobilizing effect of atorvastatin in autologous hematopoietic stem cell transplantation 2. Design Double-blind randomized placebo-controlled trial 3. Setting and conduct Forty four hospitalized patients admitted for autologous stem cell transplantation will be allocated to either intervention or control groups using permuted block randomization model 4. Participants All patients candidates for autologous stem cell transplantation with primary diagnoses of Hodgkin's lymphoma, non-Hodgkin's lymphoma or multiple myeloma; who age at least 18 years old; and endorse the inform consent will be recruited. Patients who are taking any statin drug (lovastatin, simvastatin, atorvastatin, fluvastatin, rozuvastatin) at the time of enrollment; or develop suspected drug related toxicity during treatment will be excluded from study 5. Intervention Patients allocated to intervention group will receive atorvastatin 40 mg daily initiated at the time of hospitalization and continued to the day of cell harvest plus standard filgrastim regimen. Patients allocated to control group will receive placebo on a daily basis initiated at the time of hospitalization and continued to the day of cell harvest plus standard filgrastim regimen 6. Main outcome measures Primary outcome is the mean number of hematopoietic progenitor cells per microliter of peripheral blood before cell harvest. Secondary outcomes consist of occurrence of bleeding or infectious episodes, mean dose of filgrastim needed for stem cell mobilization before cell harvest or for engrftment after transplantation, time of leukocyte and platelet engraftments, duration of hospitalization and mortality

Vice Chancellor for Research, Tehran University of Medical Sciences