The findings come from a comparative analysis of two completed national phase II and phase III clinical trials that will be presented Dec. 8, 8:00 a.m. PT, at the 45th annual meeting of the American Society of Hematology (ASH) in San Diego, Calif.

The two multicenter clinical trials compare the antibody rituximab plus fludarabine, a chemotherapeutic drug, to fludarabine alone. Rituximab is an antibody-based drug approved for lymphoma. Physicians now use fludarabine alone as the current standard therapy for CLL.

The findings of the two studies show that after an average of 43 months, rituximab plus the drug fludarabine increases progression-free survival by 22 percent and overall survival by 12 percent compared to fludarabine alone.

"The findings are the first of any tested modern therapy to show a significant improvement in overall survival for people with CLL," says study leader John C. Byrd, a medical oncologist with The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. Byrd will present the findings at ASH.

"The results suggest that rituximab is going to be an extremely important drug in the treatment of this disease."

An estimated 7,300 Americans will be diagnosed with CLL in 2003, and 4,400 people are expected to die of the disease. The disease causes no symptoms initially. Doctors usually diagnose it through routine blood tests; average age at diagnosis is 62. Early stage patients can live 10 years or more, but patients with more advanced disease may live only 18 months to three years.

Rituximab is a monoclonal antibody that targets a protein known as CD20 found on immune cells known as B l
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Contact: Darrell E. Ward
Ward-15@medctr.osu.edu
614-293-3737
Ohio State University
8-Dec-2003