IDEC-C2B8 (Rituximab) Anti-CD20 Monoclonal Antibody Therapy in Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma

摘要: IDEC-C2B8 is a chimeric monoclonal antibody (MoAb) directed against the B-cell-specific antigen CD20 expressed on non-Hodgkin's lymphomas (NHL). The MoAb mediates complement and antibody-dependent cell-mediated cytotoxicity has direct antiproliferative effects malignant B-cell lines in vitro. Phase I trials of single doses up to 500 mg/m2 4 weekly 375 showed clinical responses with no dose-limiting toxicity. We conducted phase II, multicenter study evaluating four infusions patients relapsed low-grade or follicular NHL (Working Formulation groups A-D). Patients were monitored for adverse events, pharmacokinetics, response. Thirty-seven median age 58 years (range, 29 81 years) treated. All had after chemotherapy (median 2 prior regimens) 54% failed aggressive chemotherapy. Infusional side (grade 1-2) consisting mild fever, chills, respiratory symptoms, occasionally hypotension observed mostly initial infusion rare subsequent doses. Peripheral blood depletion occurred rapidly, recovery beginning 6 months posttreatment. There significant changes mean IgG levels infections not increased over what would be expected this population. Clinical remissions 17 (3 complete 14 partial remissions), yielding an intent treat response rate 46%. onset these tumor was as soon 1 month posttreatment reached maximum by In responders, time progression 10.2 (5 exceeding 20 months). Likelihood associated histology, ability sustain high serum level first infusion, longer duration remission One patient developed detectable but quantifiable immune that significance. dose weeks antitumor activity NHL. Results brief, outpatient treatment compare favorably results standard chemotherapy, better safety profile. Further studies other types lymphoma either alone combined are warranted.