Non Hodgkin Lymphoma Clinical Trial
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Eligibility Criteria
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:
Anti-cancer therapy
Glucocorticosteroids unless less than 10 mg prednisolone/day
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
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There is 1 Location for this study
Iowa City Iowa, 52242, United States
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