Phase II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in combination with rituximab in patients with recurrent B-cell non-Hodgkin lymphoma.

摘要: Summary Oblimersen sodium plus rituximab was evaluated in relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) patients. Oblimersen administered as a continuous intravenous infusion at daily dose of 3 mg/kg/d for 7 d on alternate weeks 3 weeks. Rituximab given weekly 375 mg/m2 six doses. Patients with stable disease or objective response were allowed to receive second course treatment. The overall rate (ORR) 42% 10 complete responses (CR) and eight partial (PR). Twelve (28%) patients achieved minimal disease. Among the 20 follicular ORR 60% (eight CR, four PR). Three responders refractory prior treatment rituximab, two occurred who had failed an autologous stem cell transplant. Median duration 12 months. Most toxicities low grade reversible. In conclusion, oblimersen can be safely combined rituximab. combination appears most beneficial indolent NHL warrants further investigation large randomized trial.