NCT00394836

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy

Detailed description

Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Ofatumumab	Eight weekly infusions of ofatumumab. The first infusion of 300mg ofatumunab
DRUG	Ofatumumab	followed by 7 weekly infusions of 1000mg ofatumumab

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-04-01
• Completion: 2013-09-01
• First posted: 2006-11-01
• Last updated: 2014-01-29
• Results posted: 2011-12-08

Locations

1 site across 1 country: United Kingdom