drugset / Trial / NCT01767714

Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

NCT01767714

Phase 3 Completed 100 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day \[GRAN® only\]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.

Timeline

Start
2013-04
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule 0.24 mg/kg Subcutaneous
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications