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.
Publication types
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Aged
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Aged, 80 and over
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Alemtuzumab
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Antibodies, Monoclonal, Humanized / administration & dosage
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Antibodies, Monoclonal, Humanized / adverse effects
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Antibodies, Monoclonal, Humanized / therapeutic use*
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Antibodies, Monoclonal, Murine-Derived / administration & dosage
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use
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Chlorambucil / administration & dosage
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Cyclophosphamide / administration & dosage
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Cytomegalovirus / physiology
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Cytomegalovirus Infections / etiology
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Dose-Response Relationship, Immunologic
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Drug Administration Schedule
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Drug Resistance, Neoplasm
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Female
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Follow-Up Studies
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Hematologic Diseases / chemically induced
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Humans
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Infusions, Intravenous
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Injections, Subcutaneous
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Kaplan-Meier Estimate
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Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
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Male
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Middle Aged
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Rituximab
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Salvage Therapy*
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Vidarabine / administration & dosage
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Vidarabine / analogs & derivatives
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Vidarabine / pharmacology
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Virus Activation
Substances
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Antibodies, Monoclonal, Humanized
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Antibodies, Monoclonal, Murine-Derived
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Antineoplastic Agents
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Chlorambucil
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Alemtuzumab
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Rituximab
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Cyclophosphamide
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Vidarabine
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fludarabine