title: Low dose alemtuzumab in patients with fludarabine-refractory chronic lymphocytic leukemia.
abstract: Alemtuzumab has been shown to be effective in poor-prognosis chronic lymphocytic leukemia (CLL); treatment, however, has been associated with significant toxicity. With the aim of seeking better tolerability, we treated 39 patients with fludarabine-refractory CLL subcutaneous alemtuzumab 10 mg three times a week, for 18 weeks. In 18 randomly selected patients, after obtaining lymphocyte count reduction by 1 Log, the antibody was administered once weekly at the dose of 30 mg. Overall response rate was 44%, including 8% complete remissions. Median overall survival and progression free survival were 29.1 and 10.3 months, respectively. Treatment was well tolerated, severe non-CMV infection occurred in 7% of the patients. CMV reactivation was detected in 27% of the patients, with only one case of CMV disease. No deaths occurred during therapy. In conclusion, low-dose alemtuzumab shows a promising safety profile coupled with satisfactory effectiveness in this category of poor prognosis CLL patients.
authors.affiliation: Department of Medical Sciences, University of Milan, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gritti
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Reda
authors.forename: Francesco
authors.initials: F
authors.lastname: Maura
authors.forename: Alfonso
authors.initials: A
authors.lastname: Piciocchi
authors.forename: Luca
authors.initials: L
authors.lastname: Baldini
authors.forename: Stefano
authors.initials: S
authors.lastname: Molica
authors.forename: Antonino
authors.initials: A
authors.lastname: Neri
authors.forename: Agostino
authors.initials: A
authors.lastname: Cortelezzi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002699:Chlorambucil / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D003587:Cytomegalovirus / Q000502:physiology; D003586:Cytomegalovirus Infections / Q000209:etiology; D004306:Dose-Response Relationship, Immunologic; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D016879:Salvage Therapy; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000494:pharmacology; D014775:Virus Activation
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D002699:Chlorambucil; D000074323:Alemtuzumab; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine