drugset / Trial / NCT00384150

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

NCT00384150 ↗

Phase 3 Terminated 16 enrolled Biogen
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.

Timeline

Start
2007-11
Primary completion
2010-01
Completion
2010-01

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject galiximab Monoclonal antibody 500 mg/m2 Intravenous

Indications