A randomized trial of leukapheresis volumes, 7 L versus 10 L: an assessment of efficacy and patient tolerance.

High-dose chemotherapy followed by autologous PBSC transplantation (PBSCT) has become an accepted form of therapy for a number of malignant hematologic diseases. The optimal method for the collection of PBSC is yet to be defined. Large-volume leukapheresis may be able to collect adequate numbers of PBSC with the patient undergoing fewer procedures. We routinely process 7 L of blood per leukapheresis. Hence, we elected to assess whether a modest increase in the blood volume processed would, on average, decrease the number of leukaphereses each patient needed to undergo to collect > or =2 x 10(6) CD34+ cells/kg body weight. Sixty patients were randomized to undergo 7 L leukaphereses (n = 31 patients; 87 leukaphereses) or 10 L leukaphereses (n = 29 patients; 81 leukaphereses). The median number of leukaphereses required per patient to collect the target number of CD34+ cells was two (range one to five) for both groups (p = 0.83). The median number of nucleated cells collected per patient was greater for the 10 L group (8.2 x 10(8)/kg versus 5.3 x 10(8)/kg, p = 0.005), as was the median number of mononuclear cells (MNC) (4.7 x 10(8)/kg versus 3.6 x 10(8)/kg, p = 0.0001), whereas there was no statistical difference between the groups for the median number of CD34+ cells collected per patient (3.2 x 10(6)/kg versus 3.7 x 10(6)/kg, p = 0.98). Therefore, over the 18-month period of this trial, the use of a 10 L leukapheresis volume did not decrease the number of leukaphereses performed compared with a 7 L leukapheresis volume.