Genmab announced it has completed recruitment of 75 patients in the Phase II study of Arzerra(TM) (ofatumumab) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.
Copenhagen, Denmark | July 24, 2009 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 75 patients in the Phase II study of Arzerra(TM) (ofatumumab) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.
About the study
In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of up to 24 months after treatment start. After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60.
The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
SOURCE: Genmab
Post Views: 123
Genmab announced it has completed recruitment of 75 patients in the Phase II study of Arzerra(TM) (ofatumumab) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.
Copenhagen, Denmark | July 24, 2009 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of 75 patients in the Phase II study of Arzerra(TM) (ofatumumab) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.
About the study
In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of up to 24 months after treatment start. After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60.
The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
SOURCE: Genmab
Post Views: 123
