Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
The vast majority of patients with CLL are elderly and often they cannot tolerate standard
multi-agent chemotherapeutic or biochemotherapeutic approaches. Based on this, less toxic
and more effective treatment options are needed.
Ofatumumab has proven to be effective in patients with relapsed and/or refractory CLL.
Previous studies have shown that ofatumumab is more effective than rituximab at activating
complement and utilizing complement-dependent cytotoxicity (CDC).
This study will investigate treating relapsed/refractory CLL patients with FFP in
combination with ofatumumab. The hypothesis is that patients with CLL have low complement
levels and when they get treated with humanized antibodies like rituximab or ofatumumab
these levels drop even further. Both these antibodies utilize complement to exert their
cytotoxic effect, thus we hypothesize that by replacing complement levels with FFP we can
enhance the efficacy of ofatumumab.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to therapy
Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
Up to 2 years
Joseph Tuscano, MD
University of California, Davis
United States: Food and Drug Administration
|University of California Comprehensive Cancer Center||Sacramento, California 95817|