Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

Inclusion Criteria:

• Relapsed or refractory follicular lymphoma grade I-II
• Tumor verified to be CD20 positive
• CT scan showing demarcated lesions

Exclusion Criteria:

• Previous treatment with rituximab resulting in less than partial response

• Previous radioimmunotherapy

• Previous stem cell transplantation

• Received the following treatments within 4 weeks prior to entering this study:

  1. Anti-cancer therapy
  2. Glucocorticosteroids unless less than 10 mg prednisolone/day
  3. Radiotherapy

• Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial

• HIV positivity

• Hepatitis B or hepatitis C

• Uncontrolled or chronic bacterial, fungal or viral infection

• Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer

• Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases

• WHO performance status of 3 or 4

• If you are participating in another trial with a different new drug 4 weeks before you enter this trial

• Current participation in any other clinical study

• Pregnant or breast-feeding women

• Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial