Abstract
6572 Background: Oblimersen sodium (Genasense;GNS), a phosphorothioate 18-mer antisense oligonucleotide directed against the first 6 codons of Bcl-2 mRNA, enhances the anti-tumor activity of rituximab (RIT) in NHL cell lines and lymphoma xenografts. We are conducting a phase II study to determine the efficacy and toxicity of GNS plus RIT in recurrent B-cell NHL and to evaluate the effects of this combination on the level of Bcl-2 expression, correlating this with clinical and molecular response. Methods: Pts are required to have recurrent B-cell NHL, absolute neutrophil count of ≥ 1000, platelet count of ≥ 75,000, and serum creatinine ≤ 1.8 mg/dL. GNS (3mg/kg/d) is administered as continuous IV infusion for 7 days in weeks 1, 3, and 5 (days1–7, 15–21, 29–35). Rituximab (375mg/m2) is given weekly for 6 doses (days 3,8,15,22,29). Results: Twenty-one pts have been entered to date (median age: 63 y, range 37–82; median no. prior treatments: 2, range 1–3). Eight pts had follicular lymphoma (FL), 6 small lymphocytic lymphoma (SLL), 2 mucosa- associated lymphoid tissue (MALT) lymphoma, 3 mantle cell lymphoma (MCL), and 2 large cell lymphoma (LCL). Fifteen pts are evaluable. The overall response rate is 33%. One pt with MALT achieved a CR (6%), four pts (3 FL, 1 MCL) achieved a PR (26%), one pt (FL) had minimal response (6%), and 7 had stable disease (46%). Two responders had a relapse within 6 months of the prior therapy and one response occurred in a RIT-refractory patient. Common grade 3–4 toxicities included: reversible neutropenia in 7 pts (36%), thrombocytopenia in 2 pts (10%), and non-neutropenic fever in 4 pts (21%), Conclusions: Combined therapy with GNS and RIT is feasible and has clinical activity in both aggressive and indolent recurrent NHL. Accrual is ongoing and additional data is needed to better define the activity of this regimen. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genta Genta Genta
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
