Mobilization of hematopoietic progenitor stem cells in allogeneic setting with lenograstim by subcutaneous injection, in daily or twice-daily dosing: A single-center prospective study with historical control

Background Although the mobilization of hematopoietic progenitor stem cells from healthy donors (HDs) using granulocyte-colony-stimulating factor is widely used, the ideal method for the administration of the cytokine has not yet been determined. Study Design and Methods Seventy-five consecutive HDs received lenograstim (LENO) as mobilization agent. LENO was given subcutaneously at a dose of 10 ?g/kg in a once-daily dose (ODD) every 24 hours. Results were compared with a historical control group of 181 HDs treated with 5 ?g/kg LENO twice-daily dose (TDD) with a time interval of 12 hours. Results CD34+ cell concentrations evaluated on Day 4 and on Day 5 were 45 × 10⁶ (range, 6 × 10⁶-217 × 10⁶)/L and 75 × 10⁶ (range, 7 × 10⁶-279 × 10⁶)/L with ODD versus 36 × 10⁶ (range, 3 × 10⁶-200 × 10⁶)/L and 55 × 10⁶ (range, 3 × 10⁶-738 × 10⁶)/L with TDD (p = 0.067 and p = 0.001). The collected CD34+ cell counts in first apheresis procedure were 5.6 × 10⁶ ± 2.9 × 10⁶ and 5.7 × 10⁶ ± 3 × 10⁶/kg donor and recipient body weight in the ODD versus 5.4 × 10⁶ ± 3.8 × 10⁶ and 5.3 × 10⁶ ± 3.5 × 10⁶/kg in the TDD cohort, respectively (p = 0.08 and p = 0.02). Five HDs (6.7%) mobilized CD34+ cells of fewer than 2 × 10⁶/kg recipient body weight in the ODD group compared with seven HDs (3.9%) in the TDD group (p = 0.3). ConclusionS Once-daily administration of LENO is at least as effective as twice-daily administration for the mobilization of CD34+ cells in HDs.