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Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL
Date:12/9/2008

atients in this group could receive all six of the intended courses compared with an historic high-risk group treated with FCR. There was no significant difference in incidence of infection during treatment with CFAR compared to FCR, with the exception of cytomegalovirus (CMV) reactivation. Follow-up continues for the patients treated on this trial to evaluate responses in all 60 enrolled patients and time-to-event endpoints.

Abstract #329

Subcutaneous Alemtuzumab (Campath) in Fludarabine-Refractory CLL: Final Results of the CLL2H Trial of the GCLLSG and Comprehensive Analysis of Prognostic Markers

The multicenter trial evaluated subcutaneous alemtuzumab given three times weekly at 30 mg in fludarabine refractory CLL. From September 2002 to February 2006, 103 patients were enrolled and received at least one dose of alemtuzumab. Median age was 63 years.

Subcutaneous treatment was performed on an outpatient basis in 96 percent of patients and had to be temporarily interrupted in 65 patients due to neutropenia (27 percent), anemia (three percent), thrombocytopenia (eight percent), infections (36 percent), and was stopped early in 65 cases due to insufficient response (43 percent), hematotoxicity (14 percent) and infections (29 percent). The median alemtuzumab dose given was 722 (3-2203) mg.

Toxicity observed during the treatment period was mostly grade 1/2 apart from hematotoxicity. Grade 3/4 neutropenia, thrombocytopenia, and anemia occurred in 56 percent, 57 percent, and 50 percent of patients, respectively. Grade 3/4 non-CMV infection occurred in 29 percent. CMV reactivation was observed in 15 percent total. Grade 3/4 occurred in eight percent of patients. All CMV episodes were successfully treated with anti-CMV therapy, and there was no CMV-related death. Injection site reactions occurred in 34 percent of patients and were grade 1 or 2 except in one patient
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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