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Blood, 1 October 2007, Vol. 110, No. 7, pp. 2316-2323. Prepublished online as a Blood First Edition Paper on June 20, 2007; DOI 10.1182/blood-2007-02-074641.
CLINICAL TRIALS AND OBSERVATIONS Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial1 Hematology Department, Ospedale Santa Croce, Cuneo; 2 Hematology Department, Università di Udine, Udine; 3 Hematology Department, Ospedale Cervello, Palermo, Sicily; 4 Hematology Department, Ospedale Regionale Generale, Bolzano; 5 Hematology Department, Ospedale Santa Giuseppe Moscati, Taranto; 6 Hematology Department, Ospedale Spedali Civili, Brescia; 7 Hematology Department, Ospedale Santa Antonio e Biagio, Alessandria; 8 Onco-Hematology Department, Ospedale Azienda Sanitaria Locale 5, La Spezia; 9 Internal Medicine Department, Ospedale Galliera, Genova; 10 Hematology Department, Università di Firenze, Firenze; 11 Onco-Hematology Department, Ospedale Pascale, Napoli; 12 Hematology Department, Università di Palermo, Palermo, Sicily; 13 Hematology Department, Ospedale Santa Camillo Forlanini, Roma; 14 Medical Statistics Department, Università di Torino, Torino; 15 Hemolymphopathology Department, Università di Bologna, Bologna; 16 Hematology Department, Università di Torino, Torino, Italy To evaluate in a prospective multicenter trial the feasibility and clinical efficacy of the combination of alemtuzumab (Campath-1H) with the cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) regimen (CHOP-C) as the primary treatment for patients with peripheral T-cell lymphoma (PTCL), between January 2003 and December 2005, 24 consecutive patients with PTCL entered the study and received 8 CHOP courses. Alemtuzumab was added at 30 mg subcutaneously at day –1 initially to the first 4 courses (4 patients), and then to all 8 courses (20 patients). Complete remission (CR) was achieved in 17 (71%) patients, 1 had partial remission, and 6 had stable/progressive disease. At a median follow-up of 16 months (range, 5-42 months), 14 patients were alive, 9 had died from progressive disease, and 1 had died from pneumonia at day +198 while in CR. So far, 13 are disease-free, with an overall median duration of response of 11 months. The most frequent side effects were grade 4 neutropenia and cytomegalovirus (CMV) reactivation. Major infections were Jacob-Creutzfeldt (J-C) virus reactivation, pulmonary invasive aspergillosis, Staphylococcus sepsis, and pneumonia. This study shows that CHOP-C: (1) is a feasible chemoimmunotherapy regimen; (2) is effective in PTCL with a high rate of CR achievement; and (3) is associated with mostly manageable infectious complications. This clinical trial was registered with the Osservatorio Nazionale sulla Sperimentazione cinica as ID no. 141202.
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