Alemtuzumab ( Campath-1 H ) and CHOP chemotherapy as first-line treatment of Peripheral T-cell Lymphoma : results of a GITIL prospective multicenter trial 1

To evaluate in a prospective multicenter trial the feasibility and clinical efficacy of the combination of alemtuzumab (Campath-1H) with the CHOP regimen (CHOP-C) as the primary treatment for patients with peripheral T-cell lymphoma (PTCL), between January 2003 and December 2005, 24 consecutive PTCL patients entered the study and received 8 CHOP courses, Campath was added at 30 mg. s.c. at day -1 initially to the first four courses (four patients), and then to all eight courses (20 patients). CR was achieved in 17 (71%) patients, 1 had partial remission and 6 stable/progressive disease. At a median follow-up of 16 months (5-42), 14 patients are alive, nine had died from progressive disease and one 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 effect were grade 4 neutropenia and CMV reactivation. Major infections were 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# 141202. For personal use only. on October 24, 2017. by guest www.bloodjournal.org From