We conducted a phase II, non-comparative, open-label, multicenter GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) study (CLL0809) to assess the efficacy and safety of bendamustine in combination with ofatumumab (BendOfa) in relapsed/refractory chronic lymphocytic leukemia (CLL). Forty-seven patients from 14 centers were evaluated. Therapy consisted of bendamustine (70 mg/m2) for two consecutive days every 28 days, and ofatumumab 300 mg on day 1 and 1000 mg on day 8 during the first cycle, and 1000 mg on day 1 subsequently. Treatment was administered up to 6 cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% CI, 57–84%), with 17% complete responses. After a median follow-up of 24.2 months, the overall survival was 83.6% (95% CI, 73.0–95.7%) and the progression-free survival (PFS) 49.6% (95% CI, 35.9–68.6%). The median PFS was 23.6 months. Univariate and multivariate analyses were used to identify clinical and biological characteristics associated with ORR and PFS. Myelosuppression was the most common toxicity; grade greater than or equal to3 neutropenia was observed in 61.7% of patients, however grade greater than or equal to3 infections occurred in 6% of patients. BendOfa is feasible and effective in relapsed/refractory CLL patients, including patients with high risk clinical and biological features.

Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia : a GIMEMA multicenter phase II trial / A. Cortelezzi, M. Sciumè, A.M. Liberati, D. Vincenti, A. Cuneo, G. Reda, L. Laurenti, F. Zaja, R. Marasca, A. Chiarenza, G. Gritti, L. Orsucci, S. Storti, E. Angelucci, N. Cascavilla, M. Gobbi, F.R. Mauro, F. Morabito, S. Fabris, A. Piciocchi, M. Vignetti, A. Neri, D. Rossi, D. Giannarelli, A. Guarini, R. Foà. - In: LEUKEMIA. - ISSN 0887-6924. - 28:3(2014), pp. 642-648. [Epub ahead of print] [10.1038/leu.2013.334]

Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia : a GIMEMA multicenter phase II trial

A. Cortelezzi
Primo
;
M. Sciumè;D. Vincenti;G. Reda;G. Gritti;M. Gobbi;S. Fabris;A. Neri;
2014

Abstract

We conducted a phase II, non-comparative, open-label, multicenter GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) study (CLL0809) to assess the efficacy and safety of bendamustine in combination with ofatumumab (BendOfa) in relapsed/refractory chronic lymphocytic leukemia (CLL). Forty-seven patients from 14 centers were evaluated. Therapy consisted of bendamustine (70 mg/m2) for two consecutive days every 28 days, and ofatumumab 300 mg on day 1 and 1000 mg on day 8 during the first cycle, and 1000 mg on day 1 subsequently. Treatment was administered up to 6 cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% CI, 57–84%), with 17% complete responses. After a median follow-up of 24.2 months, the overall survival was 83.6% (95% CI, 73.0–95.7%) and the progression-free survival (PFS) 49.6% (95% CI, 35.9–68.6%). The median PFS was 23.6 months. Univariate and multivariate analyses were used to identify clinical and biological characteristics associated with ORR and PFS. Myelosuppression was the most common toxicity; grade greater than or equal to3 neutropenia was observed in 61.7% of patients, however grade greater than or equal to3 infections occurred in 6% of patients. BendOfa is feasible and effective in relapsed/refractory CLL patients, including patients with high risk clinical and biological features.
Bendamustine; Chronic lymphocytic leukemia; Ofatumumab; Relapse
Settore MED/15 - Malattie del Sangue
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/227638
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