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

2013; Springer Nature; Volume: 28; Issue: 3 Linguagem: Inglês

10.1038/leu.2013.334

1476-5551

Agostino Cortelezzi, Mariarita Sciumè, A. M. Liberati, Daniele Vincenti, Antonio Cuneo, Gianluigi Reda, Luca Laurenti, Francesco Zaja, Roberto Marasca, Annalisa Chiarenza, Giuseppe Gritti, Lorella Orsucci, Sergio Storti, Emanuele Angelucci, Nicola Cascavilla, Marco Gobbi, Francesca Romana Mauro, Fortunato Morabito, Sonia Fabris, Alfonso Piciocchi, Marco Vignetti, Antonino Neri, Davide Rossi, Diana Giannarelli, Anna Guarini, Robin Foà,

Immunodeficiency and Autoimmune Disorders

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.