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

Phase 2 Completed 59 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 2007-06
Primary completion: 2009-04
Completion: 2010-09

Publications

Background Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ofatumumab	Monoclonal antibody	500 mg	Intravenous
Comparator	Ofatumumab	Monoclonal antibody	1000 mg	Intravenous
Comparator	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Comparator	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Comparator	Prednisolone	Other / unclassified	100 mg	Oral
Comparator	Prednisone	Other / unclassified	100 mg	Oral
Comparator	Vincristine	Small molecule	1.4 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications