An Open-Labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
- Circulating lymphocytes above a specific level
- Circulating lymphocytes showing certain markers
- Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment
- Previous stem cell transplantation.
- Received any of the following treatments within 4 weeks prior to entering this trial:
A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C)
- HIV positivity.
- Hepatitis B or hepatitis C.
- Other cancerous diseases, except certain skin cancers and cervix cancer.
- Certain serious medical conditions, including kidney or liver disease, some
psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
- Participation in another trial with a different new drug 4 weeks prior to enrollment
- Current participation in any other clinical study.
- Pregnant or breast-feeding women.
- Women of childbearing age who are unable or unwilling to use adequate contraception.