We conducted a phase II, noncomparative, 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/m(2)) for 2 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 six cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% confidence of interval (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) was 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 ≥3 neutropenia was observed in 61.7% of patients; however, grade ≥3 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 / Cortelezzi, A; Sciumè, M; Liberati, A. M; Vincenti, D; Cuneo, A; Reda, G; Laurenti, L; Zaja, F; Marasca, Roberto; Chiarenza, A; Gritti, G; Orsucci, L; Storti, S; Angelucci, E; Cascavilla, N; Gobbi, M; Mauro, F. R; Morabito, F; Fabris, S; Piciocchi, A; Vignetti, M; Neri, A; Rossi, D; Giannarelli, D; Guarini, A; Foà, R.. - In: LEUKEMIA. - ISSN 0887-6924. - STAMPA. - 28:3(2014), pp. 642-648. [10.1038/leu.2013.334]

Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial

MARASCA, Roberto;
2014

Abstract

We conducted a phase II, noncomparative, 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/m(2)) for 2 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 six cycles. The overall response rate (ORR), as per intention-to-treat analysis, was 72.3% (95% confidence of interval (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) was 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 ≥3 neutropenia was observed in 61.7% of patients; however, grade ≥3 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.
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Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial / Cortelezzi, A; Sciumè, M; Liberati, A. M; Vincenti, D; Cuneo, A; Reda, G; Laurenti, L; Zaja, F; Marasca, Roberto; Chiarenza, A; Gritti, G; Orsucci, L; Storti, S; Angelucci, E; Cascavilla, N; Gobbi, M; Mauro, F. R; Morabito, F; Fabris, S; Piciocchi, A; Vignetti, M; Neri, A; Rossi, D; Giannarelli, D; Guarini, A; Foà, R.. - In: LEUKEMIA. - ISSN 0887-6924. - STAMPA. - 28:3(2014), pp. 642-648. [10.1038/leu.2013.334]
Cortelezzi, A; Sciumè, M; Liberati, A. M; Vincenti, D; Cuneo, A; Reda, G; Laurenti, L; Zaja, F; Marasca, Roberto; Chiarenza, A; Gritti, G; Orsucci, L; Storti, S; Angelucci, E; Cascavilla, N; Gobbi, M; Mauro, F. R; Morabito, F; Fabris, S; Piciocchi, A; Vignetti, M; Neri, A; Rossi, D; Giannarelli, D; Guarini, A; Foà, R.
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