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

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

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.

Inclusion Criteria

• Patient with follicular lymphoma grade 1 - 2
• Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
• failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
• disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
• disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
• Tumor verified to be CD20+ positive from excisional lymph node biopsy
• CT scan in screening phase (based on local evaluation) showing:
• 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
• 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
• ECOG Performance Status of 0, 1, or 2
• Age ≥ 18 years
• Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Exclusion Criteria

• Previous autologous stem cell transplantation within 6 months
• Previous allogeneic stem cell transplantation
• More than 1 previous radio immunotherapy regimen
• Received radio immunotherapy within 3 months
• Received any Anti-cancer treatment within 4 weeks
• Received monoclonal antibodies, other than rituximab within 3 months
• Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
• Life expectancy less than 6 months