A Randomized Trial of Leukapheresis Volumes, 7 L versus 10 L: An Assessment of Efficacy and Patient Tolerance

Abstract

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.

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

“…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. 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.…”

“…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.…”

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

“…Schwarer et al 6 compared standard volume with large volume in patients with a variety of malignant hematologic diseases undergoing PBSC mobilization and reported no difference between two groups regarding numbers of aphereses and collected CD34 ؉ cells. 6 Based on the limited data available on this issue in the literature, we decided to conduct a randomized comparison of leukapheresis volume 8 l with 12 l to evaluate whether or not the larger volume would decrease the number of leukaphereses by increasing the numbers of CD34 ϩ cells/kg collected.…”

“…8,9 On the basis of those observations, some authors have suggested that processing larger volumes of peripheral blood during each leukapheresis procedure may collect a larger number of CD34 ϩ cells than processing of one to two patient blood volumes. 5,6,8,9 LVL take a proportionally longer time for the patient and are more likely to be associated with adverse events, such as citrate reactions, intravenous access difficulties, patient discomfort, anemia and thrombocytopenia. Kobbe et al 5 investigated the effect of LVL on the collected stem cell yields of allogeneic donors and showed that LVL is safe and effective in maximizing the total number of harvested progenitor cells in healthy individuals.…”

Successful mobilization of peripheral blood stem cells using recombinant human stem cell factor in heavily pretreated patients who have failed a previous attempt with a granulocyte colony-stimulating factor-based regimen

“…18 Between January 1998 and December 2002 patients were leukapheresed exclusively on a Fenwal CS3000 plus (Baxter, Deerfield, IL, USA). However, between December 2002 and August 2004 leukapheresis was performed either on the Fenwal CS 3000 plus or the Cobe Spectra (Gambro BCT, Lakewood, CO, USA).…”