NCT00363636

A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.

Conditions

• Lymphoma, Non-Hodgkin's

Interventions

Type	Name	Description
DRUG	Galiximab in combination with rituximab	Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
DRUG	Rituximab in combination with placebo	Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2006-08-15
• Last updated: 2015-10-02