A randomized trial of assessment of efficacy of leukapheresis volumes, 8 liters vs 12 liters

Abstract

Summary:It is logical to expect that large-volume leukapheresis may be able to collect adequate numbers of PBSC with fewer procedures. To date, there is no agreement on the optimal volume of leukapheresis. Therefore, in this study we compared 8 l volume with 12 l and assessed whether a 50% increase in the blood volume processed would decrease the number of leukaphereses each patient needed to collect у2.5 ؋ 10 6 CD34 ؉ cells/kg in normal mobilizers. PBSC mobilization was done with cyclophosphamide etoposide followed by rhG-CSF in all patients. Forty patients were randomized to undergo 8 l leukaphereses (n ‫؍‬ 20 patients) or 12 l leukaphereses (n ‫؍‬ 20). The median numbers of leukaphereses required in order to collect у2.5 ؋ 10 6 CD34 ؉ cells/kg in patients processed with 8 l and 12 l were 1 (range 1-5) and 1 (1-4), respectively (P ‫؍‬ 0.50). The median number of total nucleated cells (TNC) collected per patient was greater for the 12 l group (7.47 ؋ 10 8 /kg vs 3.90 ؋ 10 8 /kg, P Ͻ 0.001), as was the median number of total mononuclear cells (TMNC) (4.26 ؋ 10 8 /kg vs 2.16 ؋ 10 8 /kg, P Ͻ 0.001), whereas there was no difference between the two groups for the median number of CD34 ؉ cells collected per patient (8.94 ؋ 10 6 /kg vs 8.60 ؋ 10 6 /kg, P ‫؍‬ 0.85). The TNCs and TMNCs collected per leukapheresis were again greater for the 12 l group (3.64 ؋ 10 8 /kg vs 1.91 ؋ 10 8 /kg, P ‫؍‬ 0.001 and 2.17 ؋ 10 8 /kg vs 0.88 ؋ 10 8 /kg, P Ͻ 0.001), whereas there was no difference between the two groups for the median number of CD34 ؉ cells collected per leukapheresis (3.98 ؋ 10 6 /kg vs 3.26 ؋ 10 6 /kg, P ‫؍‬ 0.90). This study showed that there is no difference between 8 l and 12 l volumes in regard to collected CD34 ؉ cells/kg and also the use of a 12 l leukapheresis volume did not decrease the number of leukaphereses performed compared with a

Large‐volume leukapheresis using femoral venous access for harvesting peripheral blood stem cells with the Fenwal CS 3000 Plus from normal healthy donors: Predictors of CD34+ cell yield and collection efficiency

“…However, a comparison study [26] of standard and large-volume leukapheresis in an autologous setting reported no difference between the two groups as regards the number of aphereses and collected CD34+ cells. A recent study [25] also found no difference between standard and large-volume leukapheresis with regard to the collected CD34+ cells/kg, plus the use of LVL did not decrease the number of aphereses performed when compared with standard-volume leukapheresis in normal mobilizers. The processing volume may be decisive depending on the PB-CD34+ cell count.…”

“…There is conflicting evidence [2,25,26] as regards the superiority of LVL over standard-volume apheresis. Passos-Coelho et al [2] suggested that LVL may be more efficient than standard-volume leukapheresis for PBSC collection, as in most cases one LVL is sufficient for the collection of enough PBSCs to support an autologous transplantation.…”

Female donors and donors who are lighter than their recipient are less likely to meet the CD34+ cell dose requested for peripheral blood stem cell transplantation

“…There is conflicting evidence in the literature with regard to the optimal blood volume to be processed during apheresis. Some studies have suggested that apheresis of large volumes may be more efficient than standard volume leukapheresis; however, several comparative studies have not been able to confirm this …”

Hematopoietic progenitor cell large volume leukapheresis (LVL) on the Fenwal Amicus blood separator

“…There does not seem to be a standard definition of the volume processed to qualify as an LVL; volumes from 12 to 35 l have been reported [5,11,15]. The use of LVL has been reported to give higher yields of CD34+ cells [5,6,8,9,11,[13][14][15][16]. LVL is accomplished by using high whole blood flow rates, extended procedure times, or both.…”