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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.
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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 trial
Andrea Gallamini1,
Francesco Zaja2,
Caterina Patti3,
Atto Billio4,
Maria Rosaria Specchia5,
Alessandra Tucci6,
Alessandro Levis7,
Annunziata Manna8,
Vicenzo Secondo9,
Luigi Rigacci10,
Antonello Pinto11,
Emilio Iannitto12,
Valerio Zoli13,
Pierfederico Torchio14,
Stefano Pileri15, and
Corrado Tarella16
1 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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