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
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