A randomized phase 2 study of PBPC mobilization by stem cell factor and filgrastim in heavily pretreated patients with Hodgkin's disease or non-Hodgkin's lymphoma

This randomized, controlled study compared the ability to mobilize and coll ect an optimal target yield of 5 x 10(6) CD34(+) cells/kg using stem cell f actor (SCF; 20 mu g/kg/day) plus filgrastim (G-CSF; 10 mu g/kg/day) ys filg rastim alone (10 mu g/kg/day) in 102 patients diagnosed with non-Nodgkin's lymphoma (NHL) or Hodgkin's disease (HD), who were prospectively defined as being heavily pretreated. Leukapheresis began on day 5 of cytokine? admini stration and continued daily until the target yield was reached, or until a maximum of five leukaphereses had been performed, Compared with the filgra stim-alone group (n = 54), the SCF plus filgrastim group (n = 48) showed an increase in the proportion of patients reaching the target yield within fi ve leukaphereses (44% ys 17%, P = 0.002); reduction in the number of leukap hereses required to reach the target yield (P = 0.003); reduction in the pr oportion of patients failing to reach a minimum yield of 1 x 10(6) CD34(+) cells/kg to proceed to transplant (16% Its 26%, P = NS); increase in the me dian yield of CD34(+) cells per leukapheresis (0.73 x 10(6)/kg vs 0.48 x 10 (6)/kg, P = 0.04); and an increase in the median total CD34(+) cells collec ted within five leukaphereses (3.6 x 10(6)/kg vs 2.4 x 10(6)/kg, P = 0.05), All patients receiving SCF were premedicated (antihistamines and albuterol ), and treatment was generally well tolerated, Five patients experienced se vere mast cell-mediated reactions, none of which were life-threatening. In this study of heavily pretreated lymphoma patients, SCF plus filgrastim was more effective than filgrastim alone for mobilizing PBPC for harvesting an d transplantation after high-dose chemotherapy.