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Blood, 15 April 2004, Vol. 103, No. 8, pp. 2920-2924.
Prepublished online as a Blood First Edition Paper on December 30, 2003; DOI 10.1182/blood-2003-10-3389.

Submitted October 3, 2003
Accepted December 12, 2003
A pilot study of alemtuzumab (anti-CD52 monoclonal antibody) therapy for patients with relapsed or chemotherapy-refractory peripheral T-cell lymphomas
Gunilla Enblad*, Hans Hagberg, Martin Erlanson, Jeanette Lundin, Anja Porwit MacDonald, Roland Repp, Johannes Schetelig, Gernot Seipelt, and Anders Osterborg
Department of Oncology, University Hospital Uppsala, Uppsala, Sweden
Umea University Hospital, Umea, Sweden
Department of Hematology/Oncology, Karolinska Hospital, Stockholm, Sweden
Departments of Pathology, Karolinska Hospital, Stockholm, Sweden
Department of Medicine, University of Erlangen, Erlangen, Germany
Department of Medicine, University Hospital Carl Gustav Carcus, Dresden, Germany
Department of Hematology/Oncology, University Hospital, Frankfurt, Germany
* Corresponding author; email: Gunilla.Enblad{at}onkologi.uu.se.
Patients with peripheral T-cell lymphomas (PTLs) have an extremely poor prognosis when relapsed or refractory to conventional chemotherapy. We have studied alemtuzumab, a humanized anti-CD52 monoclonal antibody, as therapy for patients with heavily pretreated and refractory PTL. Fourteen patients entered the study. All had clinical stage III or IV disease. Patients received a rapidly escalating dose of alemtuzumab during the first week; thereafter, 30 mg intravenously tiw for a maximum of 12 weeks. Trimethoprim/sulphamethoxazole and valaciclovir prophylaxis was given to all patients. The overall response rate was 36% (5/14). Three patients achieved a complete remission (CR) and two patients a partial remission. The durations of the CRs were 2, 6 and 12 months, respectively. Toxicity included cytomegalovirus reactivation in six patients, which was successfully treated with ganciclovir or foscarnet; pulmonary aspergillosis in two patients; and pancytopenia in four patients. Epstein-Barr virus-related hemophagocytosis was observed in two patients. Five patients died of causes related to the treatment, in combination with advanced disease. We conclude that alemtuzumab is active when used in patients with advanced, heavily pretreated PTL, although it is associated with significant hematologic toxicity and infectious complications. Further studies are warranted in younger patients and patients with less-advanced disease.

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