NCT00850499

Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	fludarabine	fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
DRUG	rituximab	rituximab 375mg/m2 on Day 1 of every 35-day cycle
DRUG	VELCADE	1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2009-02-25
• Last updated: 2012-12-12
• Results posted: 2012-11-01

Locations

43 sites across 7 countries: France, Germany, Greece, Israel, Italy, Spain, Switzerland