Investigation of monoclonal antibody therapy with conventional and high-dose treatment: current clinical trials.

The approval of rituximab for recurrent low-grade or follicular B-cell malignancy has created marked interest in CD20-targeted therapy in a wide range of patients, including those who have not previously been treated or who have other tumor types. Due to anti-CD20's single-agent activity and nonoverlapping toxicity with conventional treatments, combination therapy incorporating monoclonal antibodies has become the focus of intense investigation. Phase 2 studies indicate that rituximab can be administered safely with conventional and high-dose chemotherapy regimens commonly used to treat non-Hodgkin's lymphoma (NHL); however, it has not been established whether combined treatment results in increased efficacy. Randomized, prospective phase 3 investigations of rituximab in combination with chemotherapy are currently ongoing. Investigators are encouraged to evaluate and enroll as many patients as possible in these and other important trials.