granulocyte colony-stimulating factor + placebo (Sanofi)

Granulocyte colony-stimulating factor (G-CSF) plus placebo refers to the control treatment regimen used in the pivotal Phase 3 clinical trial (NCT00103311) conducted by Genzyme (now a Sanofi company) to evaluate the efficacy of plerixafor (Mozobil) for hematopoietic stem cell mobilization. In this trial, patients with non-Hodgkin's lymphoma (NHL) undergoing autologous transplantation received G-CSF (typically filgrastim) at a dose of 10 µg/kg daily for up to 8 days, with a placebo injection administered starting on the evening of Day 4. This regimen served as the active comparator to the plerixafor plus G-CSF arm. The trial demonstrated that the addition of plerixafor to G-CSF significantly improved the mobilization of CD34+ cells compared to G-CSF plus placebo, leading to the FDA approval of plerixafor in 2008.

Other names

G-CSF + placebofilgrastim + placebo