Study design

This was an international, multicenter, non-interventional registry study, with patient follow-up ranging from 3.5 to 7.5 years, which evaluated the outcomes for patients with lymphoma who received G-CSF + plerixafor compared with other mobilization methods for HSC mobilization and who received an autologous HSCT (ClinicalTrials.gov number {"type":"clinical-trial","attrs":{"text":"NCT01362972","term_id":"NCT01362972"}}NCT01362972). All patients ≥18 years from the EBMT registry, with a diagnosis of lymphoma who were considered poor mobilizers and had undergone their first autologous HSCT between 2008 and 2012, were considered eligible for the study. Patients in the plerixafor groups who were poor mobilizers were those treated according to the label. Patients enrolled in the registry and evaluated in this study were from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, and the United Kingdom.

The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. Approval of the protocol was obtained from all participating sites, local governmental authorities, and Institutional Review Boards. This was a non-inferiority study, with a non-inferiority margin of a 30% increase in PFS and OS corresponding to a hazard ratio (HR) upper bound of 1.3; no lower limit was set.