TY - JOUR
T1 - Bendamustine in combination with Ofatumumab in relapsed or refractory chronic lymphocytic leukemia
T2 - A GIMEMA Multicenter Phase II Trial
AU - Cortelezzi, A.
AU - Sciumè, M.
AU - Liberati, A. M.
AU - Vincenti, D.
AU - Cuneo, A.
AU - Reda, G.
AU - Laurenti, L.
AU - Zaja, F.
AU - Marasca, R.
AU - Chiarenza, A.
AU - Gritti, G.
AU - Orsucci, L.
AU - Storti, S.
AU - Angelucci, E.
AU - Cascavilla, N.
AU - Gobbi, M.
AU - Mauro, F. R.
AU - Morabito, F.
AU - Fabris, S.
AU - Piciocchi, A.
AU - Vignetti, M.
AU - Neri, A.
AU - Rossi, D.
AU - Giannarelli, D.
AU - Guarini, A.
AU - Foà, R.
PY - 2014/3
Y1 - 2014/3
N2 - 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.
AB - 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.
KW - Bendamustine
KW - Chronic lymphocytic leukemia
KW - Ofatumumab
KW - Relapse
UR - http://www.scopus.com/inward/record.url?scp=84895833178&partnerID=8YFLogxK
U2 - 10.1038/leu.2013.334
DO - 10.1038/leu.2013.334
M3 - Article
SN - 0887-6924
VL - 28
SP - 642
EP - 648
JO - Leukemia
JF - Leukemia
IS - 3
ER -