Efficacy and safety of the single-dose pegylated G-CSF vs. daily G-CSF for peripheral blood stem cells mobilization in donors: a multicenter, randomized controlled trial

Background The mobilization of peripheral blood stem cells(PBSC) needs daily injection of granulocyte colony stimulating factor (G-CSF), which brings inconvenience to healthy donors. Can pegylated granulocyte colony-stimulating factor (Peg-G-CSF) solve this problem by single dose injection? Methods This multicenter, randomized controlled study was conducted from May 2018 to April 2019. Eligible donors were randomly selected to received treatment with 12 mg Peg-G-CSF on day 1 or 10 µg/kg/d G-CSF consecutively from day 1. PBSC apheresis of the donors was conducted on day 5. The primary endpoint was the percentage of donors who collected ≥4×10 6 CD34 + cells/kg recipient weight after single apheresis. Results Eighty (83.3%) of 96 donors in the Peg-G-SCF group and 76 (79.2%) of 96 donors in the G-CSF group collected ≥4×10 6 CD34 + cells/kg recipient weight. The peak value of circulating CD34 + cell count occurred on day 5 in both groups. The median yield of CD34 + cell collected in the Peg-G-CSF group was comparable to that in the G-CSF group by a single apheresis procedure. Moreover, the incidence of side effects in both groups was similarly, no significant difference was observed in engraftment, graft-versus-host disease (GVHD) or survival between the two groups of recipients. By multivariate analysis, The CD34 + cell count on the fifth day was the variable that may have significantly affected the CD34 + yield. Conclusion Mobilization via a single injection of Peg-G-CSF can match traditional G-CSF mobilization in terms of efficacy and safety and is expected to provide a better alternative to traditional G-CSF mobilization. Clinical Trial Registration www.chictr.org.cn , identifier ChiCTR1800015716