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 Gallamini, Francesco Zaja, Caterina Patti, Atto Billio, Maria Rosaria Specchia, Alessandra Tucci, Alessandro Levis, Annunziata Manna, Vicenzo Secondo, Luigi Rigacci, Antonello Pinto, Emilio Iannitto, Valerio Zoli, Pierfederico Torchio, Stefano Pileri, Corrado Tarella

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Abstract

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.

Original languageEnglish
Pages (from-to)2316-2323
Number of pages8
JournalBlood
Volume110
Issue number7
DOIs
Publication statusPublished - Oct 1 2007

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Peripheral T-Cell Lymphoma
Chemotherapy
T-cells
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Multicenter Studies
Drug Therapy
Pneumonia
Therapeutics
Viruses
Invasive Pulmonary Aspergillosis
Neutropenia
Cytomegalovirus
Staphylococcus
alemtuzumab
Sepsis
Clinical Trials
Infection

ASJC Scopus subject areas

  • Hematology

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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. / Gallamini, Andrea; Zaja, Francesco; Patti, Caterina; Billio, Atto; Specchia, Maria Rosaria; Tucci, Alessandra; Levis, Alessandro; Manna, Annunziata; Secondo, Vicenzo; Rigacci, Luigi; Pinto, Antonello; Iannitto, Emilio; Zoli, Valerio; Torchio, Pierfederico; Pileri, Stefano; Tarella, Corrado.

In: Blood, Vol. 110, No. 7, 01.10.2007, p. 2316-2323.

Research output: Contribution to journalArticle

Gallamini, A, Zaja, F, Patti, C, Billio, A, Specchia, MR, Tucci, A, Levis, A, Manna, A, Secondo, V, Rigacci, L, Pinto, A, Iannitto, E, Zoli, V, Torchio, P, Pileri, S & Tarella, C 2007, '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', Blood, vol. 110, no. 7, pp. 2316-2323. https://doi.org/10.1182/blood-2007-02-074641
Gallamini, Andrea ; Zaja, Francesco ; Patti, Caterina ; Billio, Atto ; Specchia, Maria Rosaria ; Tucci, Alessandra ; Levis, Alessandro ; Manna, Annunziata ; Secondo, Vicenzo ; Rigacci, Luigi ; Pinto, Antonello ; Iannitto, Emilio ; Zoli, Valerio ; Torchio, Pierfederico ; Pileri, Stefano ; Tarella, Corrado. / 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. In: Blood. 2007 ; Vol. 110, No. 7. pp. 2316-2323.
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abstract = "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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T2 - Results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial

AU - Gallamini, Andrea

AU - Zaja, Francesco

AU - Patti, Caterina

AU - Billio, Atto

AU - Specchia, Maria Rosaria

AU - Tucci, Alessandra

AU - Levis, Alessandro

AU - Manna, Annunziata

AU - Secondo, Vicenzo

AU - Rigacci, Luigi

AU - Pinto, Antonello

AU - Iannitto, Emilio

AU - Zoli, Valerio

AU - Torchio, Pierfederico

AU - Pileri, Stefano

AU - Tarella, Corrado

PY - 2007/10/1

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N2 - 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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