Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
The risk of immunosuppression deters many patients from receiving fludarabine, while
combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic
lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that
rituximab is safe and well tolerated when used as a single agent in patients with CLL. In
addition, maintenance therapy with rituximab was well tolerated by CLL patients, with
probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre
clinical and clinical studies indicating possible increased efficacy of ofatumumab in
patients with CLL, we wish to develop an antibody-only regimen for older patients and
patients who refuse fludarabine-based regimens.