NCT00494780

Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Ofatumumab	ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
DRUG	Doxorubicin	Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
DRUG	Vincristine	Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
DRUG	Prednisolone, Prednisone or equivalent	100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-04-01
• Completion: 2010-09-01
• First posted: 2007-07-02
• Last updated: 2014-07-11
• Results posted: 2011-08-26

Locations

1 site across 1 country: United States