Trial Information

Summary: If the patient has B-Cell Chronic Lymphocytic Leukemia and has not been treated previously for the disease with a cell-depleting aim, he/she may be eligible for this clinical trial.

Physicians are currently seeking subjects to participate in this open-labeled, randomized, two-dose, parallel group, phase II clinical research study of an investigational agent (ofatumumab). Patients in the trial will receive one of two possible doses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide.

Qualified subjects receive all study-related evaluations and procedures related to the study at no cost.

Main Inclusion Criteria:

• Patients with active B-CLL with an indication for treatment
• Age = 18 years

Main Exclusion Criteria:

• Any previous treatment for B-CLL with any cell depleting aim
• Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC treatment
• Current participation in any other interventional clinical study

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

US Project Manager: Zena Muzyczenko 866-887-1291
International Clinical Trial Manager: Henriette Kristensen

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