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

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Granulocyte-colony stimulating factor (G-CSF)	10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
DRUG	Plerixafor	0.24 mg/kg/day subcutaneous injection
DRUG	Placebo	0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-01-14
• Last updated: 2014-12-09

Locations

16 sites across 1 country: China