Phase II study of alemtuzumab in chronic lymphoproliferative disorders

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Abstract
BACKGROUND Pilot studies showed that alemtuzumab is active in lymphoproliferative disorders. The authors conducted a Phase II trial to evaluate the efficacy and safety of alemtuzumab in advanced or refractory chronic lymphoproliferative disorders. METHODS Seventy‐eight patients were enrolled. The most common diagnoses were chronic lymphocytic leukemia (n = 42 patients) and T‐cell prolymphocytic leukemia (n = 18 patients). Before entering the study, the patients had received multiple therapies (median, three therapies) and the median time from diagnosis was 7 years. Alemtuzumab was given intravenously at doses of 3 mg, 10 mg, and 30 mg on 3 consecutive days, after which 30 mg was administered 3 times a week. Patients were treated for 4–12 weeks depending on disease response. All patients received prophylactic trimethoprim/sulfamethoxazole and valacyclovir. RESULTS The overall response rate was 35%, the complete response (CR) rate was 13%, and the partial response (PR) rate was 22%. The median duration of response was 18 months for patients achieving a CR and 7 months for patients achieving a PR. The median duration of survival was 25 months for patients who had a response and 12 months for the entire population. Normalization of the lymphocyte count was observed in 84% of patients and resolution of bone marrow involvement was observed in 49% of patients. The most common infusion‐related adverse events were fever, rigors, skin rash, nausea, and dyspnea. These were most common during the first week of therapy. Hematologic toxicity was comprised of long‐lasting lymphocytopenia and transient neutropenia and thrombocytopenia. Thirty‐six patients (46%) experienced at least one episode of fever or infection. CONCLUSIONS Alemtuzumab has a high response rate in patients with chronic lymphoproliferative disorders. Cancer 2003;98:773–8. © 2003 American Cancer Society. DOI 10.1002/cncr.11551