drugset / Trial / NCT00092274
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Timeline
- Start
- 2004-09
- Primary completion
- 2005-01
- Completion
- 2005-01
Publications
- Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.
- Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. doi: 10.1182/blood-2007-10-117671. Epub 2008 Apr 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ofatumumab | Monoclonal antibody | 300 mg | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 500 mg | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 700 mg | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |