HuMax-CD20 in Chronic Lymphocytic Leukemia

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

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

Inclusion Criteria:

• Chronic Lymphocytic Leukemia
• Circulating lymphocytes above a specific level
• Circulating lymphocytes showing certain markers

Exclusion Criteria:

• Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
• 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) Radiotherapy.
• 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 in study.
• 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.