Trial Information

Summary: If the patient has B-Cell Chronic Lymphocytic Leukemia, has failed treatment with fludarabine, and failed or been intolerant ineligible to treatment with alemtuzumab, he/she may be eligible for this clinical trial.

Physicians are currently seeking subjects to participate in this single-arm, international, phase III clinical research study of an investigational agent. Eligible subjects will receive eight weekly infusions of the investigational agent, followed by 4 monthly infusions of the investigational agent. Subjects are asked to come to the clinic for a maximum of 21 visits over 24 months during a 24 month period. Qualified subjects receive all evaluations and procedures related to the study at no cost, including physical examinations, laboratory tests, ECG, and CT-scan. CT Scans and biopsies will be done up to 2 times during the trial.

Main Inclusion Criteria:

• Tumor cell phenotype consistent with B-CLL
• Patients with active B-CLL and with an indication for treatment
• Failing at least one fludarabine-containing treatment regimen
• Failing at least one alemtuzumab-containing treatment regimen
• Age >= 18 years
• Signed informed consent

Main Exclusion Criteria:

• Previous treatment with alemtuzumab within 6 weeks prior to Visit 1
• Previous autologous stem cell transplantation within 6 months prior to Visit 1
• Allogeneic stem cell transplantation
• Radioimmunotherapy, and other treatments
• Past or current malignancy, except for:
• Cervical carcinoma Stage 1B or less
• Non-invasive basal cell and squamous cell skin carcinoma
• Malignant melanoma with a complete response of a duration of > 10 years
• Other cancer diagnoses with a complete response of a duration of > 5 years
• Chronic or ongoing active infectious disease requiring systemic treatment
• Clinically significant cardiac disease
• Significant concurrent, uncontrolled medical condition
• History of significant cerebrovascular disease
• Breast feeding women or women with a positive pregnancy test at Visit 1
• Women of childbearing potential not willing to use adequate contraception during study and one year after last dose of HuMax-CD20.

There are additional inclusion and exclusion criteria that may be discussed with a study physician.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.