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

Transfusion. 2015 Aug;55(8):2032-8. doi: 10.1111/trf.13117. Epub 2015 Apr 9.

Abstract

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 µg/kg in a once-daily dose (ODD) every 24 hours. Results were compared with a historical control group of 181 HDs treated with 5 µg/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 × 10(6) (range, 6 × 10(6) -217 × 10(6) )/L and 75 × 10(6) (range, 7 × 10(6) -279 × 10(6) )/L with ODD versus 36 × 10(6) (range, 3 × 10(6) -200 × 10(6) )/L and 55 × 10(6) (range, 3 × 10(6) -738 × 10(6) )/L with TDD (p = 0.067 and p = 0.001). The collected CD34+ cell counts in first apheresis procedure were 5.6 × 10(6) ± 2.9 × 10(6) and 5.7 × 10(6) ± 3 × 10(6) /kg donor and recipient body weight in the ODD versus 5.4 × 10(6) ± 3.8 × 10(6) and 5.3 × 10(6) ± 3.5 × 10(6) /kg in the TDD cohort, respectively (p = 0.08 and p = 0.02). Five HDs (6.7%) mobilized CD34+ cells of fewer than 2 × 10(6) /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.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Allografts
  • Antigens, CD34 / blood
  • Blood Component Removal
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Fatigue / chemically induced
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Granulocyte Colony-Stimulating Factor / pharmacology*
  • Hematologic Diseases / therapy
  • Hematopoietic Stem Cell Mobilization / methods
  • Historically Controlled Study
  • Humans
  • Injections, Subcutaneous
  • Lenograstim
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Neoplasms / therapy
  • Pain / chemically induced
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / pharmacology
  • Treatment Outcome

Substances

  • Antigens, CD34
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Lenograstim