A randomized, double-blind trial of filgrastim (granulocyte colony-stimulating factor) versus placebo following allogeneic blood stem cell transplantation

Blood stem cell transplantation (BSCT) results in rapid hematopoietic recov ery in both the allogeneic and autologous transplant settings. Because of t he large numbers of progenitor cells in mobilized blood, the administration of growth factors after transplantation may not provide further accelerati on of hematopoietic recovery. A randomized, double-blind, placebo-controlle d study was performed to determine the effects of filgrastim (granulocyte c olony-stimulating factor; G-CSF) administration on hematopoietic recovery a fter allogeneic BSCT. Fifty-four patients with hematologic malignancies und ergoing a related, HLA-matched allogeneic BSCT were randomly assigned to re ceive daily filgrastim at 10 mu g/kg or placebo starting on the day of tran splantation. A minimum of 3 x 10(6) CD34(+) cells/kg in the allograft was r equired for transplantation. All patients received a standard preparative r egimen and a standard regimen for the prevention of graft-versus-host disea se (GVHD). The median time to achieve an absolute neutrophil count greater than 0.5 x 10(9)/L was 11 days (range, 9-20 days) for patients who received filgrastim compared with 15 days (range, 10-22 days) for patients who rece ived placebo (P = .0082). The median time to achieve a platelet count great er than 20 x 10(9)/L was 13 days (range, 8-35 days) for patients who receiv ed filgrastim compared with 15.5 days (range, 8-42 days) for patients who r eceived placebo (P = .79). There were no significant differences for red bl ood cell transfusion independence,the incidence of acute GVHD, or 100-day m ortality between the groups. The administration of filgrastim appears to be a safe and effective supportive-care measure following allogeneic BSCT. (B lood. 2000;96:80-85) (C) 2000 by The American Society of Hematology.