Trial Information

Summary: If the patient has Follicular Lymphoma and is refractory to rituximab as monotherapy or in combination with chemotherapy or to rituximab as a maintenance treatment, he/she may be eligible for this clinical trial.

Physicians are currently seeking subjects to participate in this single-arm, international, phase III clinical research study of an investigational agent. Patients will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 12 and at month 18 and 24. Qualified subjects receive all study-related evaluations and procedures related to the study at no cost.

Main Inclusion Criteria:

• Patient with follicular lymphoma grade 1 – 2
• Refractory to rituximab as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, is defined as:
  • failure to achieve at least PR to rituximab given as monohterapy 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); or,
  • disease progression in responders within 6 months of the last dose of rituximab (either given as monotheray or in combination with any chemotherapy or after rituximab maintenance treatment schedule)
• 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

Main 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 prior to Visit 2
• Received any Anti-cancer treatment within 4 weeks prior to Visit 2
• 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

There are additional inclusion and exclusion criteria that may be discussed with a study physician.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.